REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)

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ClinicalTrials.gov Identifier: NCT00271154

Recruitment Status : Completed

First Posted : December 30, 2005

Results First Posted : May 13, 2009

Last Update Posted : January 30, 2012

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm and Heart Failure

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition	Heart Failure
Intervention	Device: Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
Enrollment	684

Participant Flow

Recruitment Details	Patients were enrolled from September 2004 through September 2006 at 73 sites located in the United States, Canada, and Europe.
Pre-assignment Details	A total of 684 patients were enrolled in the study. Of these, 642 patients were attempted for cardiac resynchronization therapy (CRT) device implant. 21 were unsuccessful, leaving 621 patients successfully implanted with a CRT device. Of these 621 patients, 610 were randomized.


Arm/Group Title	CRT OFF	CRT ON
Arm/Group Description	Cardiac Resynchronization Therapy (...	Cardiac Resynchronization Therapy (...
Arm/Group Description	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Period Title: Overall Study
Started	191	419
Completed	191	419
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		CRT OFF	CRT ON	Total
Arm/Group Description		Cardiac Resynchronization Therapy (...	Cardiac Resynchronization Therapy (...	Total of all reporting groups
Arm/Group Description		Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy	Total of all reporting groups
Overall Number of Baseline Participants		191	419	610
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	191 participants	419 participants	610 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	108 56.5%	229 54.7%	337 55.2%
	>=65 years	83 43.5%	190 45.3%	273 44.8%
Age Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	191 participants	419 participants	610 participants
		61.8 (11.6)	62.9 (10.6)	62.5 (11.0)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	191 participants	419 participants	610 participants
	Female	39 20.4%	92 22.0%	131 21.5%
	Male	152 79.6%	327 78.0%	479 78.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	191 participants	419 participants	610 participants
United States		108	235	343
Spain		9	18	27
Ireland		1	4	5
Austria		2	4	6
United Kingdom		6	9	15
Italy		5	12	17
France		15	34	49
Czech Republic		0	1	1
Hungary		6	13	19
Canada		1	4	5
Belgium		1	3	4
Denmark		19	46	65
Germany		6	11	17
Norway		3	4	7
Sweden		7	17	24
Netherlands		2	4	6

Outcome Measures

1.Primary Outcome


Title	Percentage of Patients Worsened for Clinical Composite Response
Description	Patients considered worsened if they died, were hospitalized with wors...
Description	Patients considered worsened if they died, were hospitalized with worsening heart failure (HF), crossed over to other arm, demonstrated worsening in New York Heart Association (NYHA) functional class, or reported moderately/markedly worse HF symptoms compared to before CRT implant.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

All randomized patients were included using Intent to Treat (ITT).


Arm/Group Title	CRT OFF	CRT ON
Arm/Group Description:	Cardiac Resynchronization Therapy (...	Cardiac Resynchronization Therapy (...
Arm/Group Description:	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Overall Number of Participants Analyzed	191	419
Measure Type: Number Unit of Measure: Percentage of participants worsened
	21.5	16

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT OFF, CRT ON
	Comments	Null hypothesis: Percentage worsened in CRT OFF group = Percentage worsened in CRT ON group
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.10
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

2.Secondary Outcome


Title	Change in Left Ventricular End Systolic Volume, Indexed (LVESVi)
Description	The change is LVESVi measured at 12 months minus LVESVi measured at ba...
Description	The change is LVESVi measured at 12 months minus LVESVi measured at baseline. The 12-month echocardiographic measurements were made with CRT programmed off, irespective of the treatment assignment. In CRT ON patients these measurements were recorded after a 10 minute washout period. Two core laboratories performed all echo measurements.
Time Frame	Baseline to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	CRT OFF	CRT ON
Arm/Group Description:	Cardiac Resynchronization Therapy (...	Cardiac Resynchronization Therapy (...
Arm/Group Description:	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy	Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
Overall Number of Participants Analyzed	191	419
Mean (Standard Deviation) Unit of Measure: milliliters per meters squared
	-1.3 (23.4)	-18.4 (29.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	CRT OFF, CRT ON
	Comments	Null hypothesis: mean 12-month change in LVESVi in group 1 = mean 12-month change in LVESVi in group 2.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	Time of enrollment to 5 years post-implant. All AE's were collected until 12 months (North America) and 24 months (Europe) when only cardiovascular, pulmonary, system, and device-related AE's were collected. AE's reported here are as of 3/5/10.
Adverse Event Reporting Description	Serious definition Led to a death, Led to a serious deterioration in health that resulted in: a life-threatening illness or injury, a permanent impairment of a body structure or function hosp. or prolongation of existing hosp. medical or surgical intervention to prevent permanent impairment to body structure or a body function.

Arm/Group Title	CRT OFF		CRT ON		Not Randomized
Arm/Group Description	Cardiac Resynchronization Therapy (...		Cardiac Resynchronization Therapy (...		These patients were enrolled in the...
Arm/Group Description	Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy		Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy		These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
All-Cause Mortality
	CRT OFF		CRT ON		Not Randomized
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	CRT OFF		CRT ON		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	122/191 (63.87%)		268/419 (63.96%)		13/38 (34.21%)
General disorders
Cardiac failure acute ^† 1	30/191 (15.71%)	52	56/419 (13.37%)	98	2/38 (5.26%)	5
Medical device change ^† 1	19/191 (9.95%)	19	45/419 (10.74%)	46	1/38 (2.63%)	1
Ventricular tachycardia ^† 1	11/191 (5.76%)	14	30/419 (7.16%)	43	1/38 (2.63%)	1
LV lead dislodgement ^† 1	13/191 (6.81%)	15	26/419 (6.21%)	28	2/38 (5.26%)	2
Chest pain ^† 1	4/191 (2.09%)	4	21/419 (5.01%)	25	0/38 (0.00%)	0
Pneumonia ^† 1	8/191 (4.19%)	9	16/419 (3.82%)	19	1/38 (2.63%)	1
Atrial fibrillation ^† 1	8/191 (4.19%)	8	15/419 (3.58%)	19	0/38 (0.00%)	0
Device lead damage ^† 1	8/191 (4.19%)	8	18/419 (4.30%)	18	0/38 (0.00%)	0
Inappropriate device therapy ^† 1	3/191 (1.57%)	3	16/419 (3.82%)	16	0/38 (0.00%)	0
Ventricular fibrillation ^† 1	4/191 (2.09%)	4	8/419 (1.91%)	11	1/38 (2.63%)	1
Cardiac failure chronic ^† 1	5/191 (2.62%)	6	5/419 (1.19%)	6	2/38 (5.26%)	2
Chronic obstructive pulmonary disease ^† 1	3/191 (1.57%)	3	7/419 (1.67%)	11	0/38 (0.00%)	0
RV lead dislodgement ^† 1	1/191 (0.52%)	1	13/419 (3.10%)	13	0/38 (0.00%)	0
Syncope ^† 1	5/191 (2.62%)	7	5/419 (1.19%)	5	1/38 (2.63%)	1
Angina pectoris ^† 1	4/191 (2.09%)	4	8/419 (1.91%)	8	0/38 (0.00%)	0
Atrial flutter ^† 1	6/191 (3.14%)	6	4/419 (0.95%)	5	1/38 (2.63%)	1
Inappropriate device irritation of tissue ^† 1	3/191 (1.57%)	3	9/419 (2.15%)	9	0/38 (0.00%)	0
Cerebrovascular accident ^† 1	4/191 (2.09%)	5	5/419 (1.19%)	6	0/38 (0.00%)	0
Gastrointestinal hemorrhage ^† 1	6/191 (3.14%)	6	4/419 (0.95%)	5	0/38 (0.00%)	0
Hypotension ^† 1	1/191 (0.52%)	1	9/419 (2.15%)	9	1/38 (2.63%)	1
Dyspnea ^† 1	2/191 (1.05%)	3	7/419 (1.67%)	7	0/38 (0.00%)	0
Failure to capture ^† 1	5/191 (2.62%)	6	4/419 (0.95%)	4	0/38 (0.00%)	0
Lead dislodgement ^† 1	0/191 (0.00%)	0	8/419 (1.91%)	10	0/38 (0.00%)	0
RA lead dislodgement ^† 1	2/191 (1.05%)	2	8/419 (1.91%)	8	0/38 (0.00%)	0
Renal failure acute ^† 1	4/191 (2.09%)	4	6/419 (1.43%)	6	0/38 (0.00%)	0
Transient ischemic attack ^† 1	2/191 (1.05%)	2	8/419 (1.91%)	8	0/38 (0.00%)	0
Coronary artery disease ^† 1	4/191 (2.09%)	5	3/419 (0.72%)	3	0/38 (0.00%)	0
Carotid artery stenosis ^† 1	2/191 (1.05%)	2	5/419 (1.19%)	5	0/38 (0.00%)	0
Implant site hematoma ^† 1	1/191 (0.52%)	1	6/419 (1.43%)	6	0/38 (0.00%)	0
Myocardial infarction ^† 1	3/191 (1.57%)	3	4/419 (0.95%)	4	0/38 (0.00%)	0
Osteoarthritis ^† 1	2/191 (1.05%)	2	5/419 (1.19%)	5	0/38 (0.00%)	0
Pneumothorax ^† 1	0/191 (0.00%)	0	5/419 (1.19%)	6	0/38 (0.00%)	0
Acute myocardial infarction ^† 1	1/191 (0.52%)	1	4/419 (0.95%)	4	0/38 (0.00%)	0
Atrial tachycardia ^† 1	1/191 (0.52%)	1	3/419 (0.72%)	3	1/38 (2.63%)	1
Ischemic stroke ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	5	0/38 (0.00%)	0
Pericardial effusion ^† 1	2/191 (1.05%)	2	3/419 (0.72%)	3	0/38 (0.00%)	0
Peripheral vascular disorder ^† 1	1/191 (0.52%)	3	1/419 (0.24%)	1	1/38 (2.63%)	1
Renal failure ^† 1	2/191 (1.05%)	2	3/419 (0.72%)	3	0/38 (0.00%)	0
Sudden cardiac death ^† 1	2/191 (1.05%)	2	3/419 (0.72%)	3	0/38 (0.00%)	0
Acute pulmonary edema ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	1/38 (2.63%)	1
Anemia ^† 1	0/191 (0.00%)	0	4/419 (0.95%)	4	0/38 (0.00%)	0
Asthma ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	3	1/38 (2.63%)	1
Atrioventricular block complete ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	3/38 (7.89%)	3
Bradycardia ^† 1	1/191 (0.52%)	1	3/419 (0.72%)	3	0/38 (0.00%)	0
Bronchitis ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	4	0/38 (0.00%)	0
Cardiac arrest ^† 1	2/191 (1.05%)	2	2/419 (0.48%)	2	0/38 (0.00%)	0
Cholecystitis acute ^† 1	2/191 (1.05%)	2	2/419 (0.48%)	2	0/38 (0.00%)	0
Deep vein thrombosis ^† 1	2/191 (1.05%)	2	2/419 (0.48%)	2	0/38 (0.00%)	0
Implant site infection ^† 1	2/191 (1.05%)	2	1/419 (0.24%)	2	0/38 (0.00%)	0
Inappropriate device signal detection ^† 1	3/191 (1.57%)	3	1/419 (0.24%)	1	0/38 (0.00%)	0
Ischemic cardiomyopathy ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	1/38 (2.63%)	1
Lung neoplasm malignant ^† 1	2/191 (1.05%)	2	2/419 (0.48%)	2	0/38 (0.00%)	0
Respiratory failure ^† 1	1/191 (0.52%)	1	3/419 (0.72%)	3	0/38 (0.00%)	0
Acute respiratory failure ^† 1	2/191 (1.05%)	2	1/419 (0.24%)	1	0/38 (0.00%)	0
Angina unstable ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Aortic aneurysm ^† 1	2/191 (1.05%)	2	1/419 (0.24%)	1	0/38 (0.00%)	0
Atrioventricular block third degree ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Back pain ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Bronchitis acute ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Cardiac perforation ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	1/38 (2.63%)	1
Cardiac tamponade ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	1/38 (2.63%)	1
Contusion ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	1/38 (2.63%)	1
Defibrillation threshold increased ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Dehydration ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Dizziness ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	3	0/38 (0.00%)	0
Esophageal carcinoma ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Hematoma ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Intracardiac thrombus ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Myocardial ischemia ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Non-cardiac chest pain ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Pericarditis ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	3	0/38 (0.00%)	0
Presyncope ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Prostate examination abnormal ^† 1	0/191 (0.00%)	0	3/419 (0.72%)	3	0/38 (0.00%)	0
Pulmonary edema ^† 1	2/191 (1.05%)	2	1/419 (0.24%)	1	0/38 (0.00%)	0
Subclavian vein thrombosis ^† 1	1/191 (0.52%)	1	2/419 (0.48%)	2	0/38 (0.00%)	0
Therapeutic agent toxicity ^† 1	1/191 (0.52%)	2	1/419 (0.24%)	1	0/38 (0.00%)	0
Anxiety ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	1/38 (2.63%)	1
Aortic stenosis ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Arrhythmia supraventricular ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Arteriovenous fistula ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	1/38 (2.63%)	1
Biliary colic ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Cholecystitis ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Cholelithiasis ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Coronary artery dissection ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Coronary artery stenosis ^† 1	2/191 (1.05%)	2	0/419 (0.00%)	0	0/38 (0.00%)	0
Death ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Diabetes mellitus ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Diabetes mellitus inadequate control ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Drug hypersensitivity ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Drug toxicity ^† 1	1/191 (0.52%)	2	0/419 (0.00%)	0	0/38 (0.00%)	0
Dyspnea exertional ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Electromechanical dissociation ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	1/38 (2.63%)	1
Fatigue ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Heart transplant ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Hyperglycemia ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Inappropriate device stimulation of tissue ^† 1	2/191 (1.05%)	2	0/419 (0.00%)	0	0/38 (0.00%)	0
Mental status changes ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Mitral valve incompetence ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	2	0/38 (0.00%)	0
Orthostatic hypotension ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Oversensing ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Paraesthesia ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Pneumonia aspiration ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Postoperative wound infection ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Pulmonary embolism ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	2	0/38 (0.00%)	0
Pulmonary fibrosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	2	0/38 (0.00%)	0
Sepsis ^† 1	1/191 (0.52%)	1	1/419 (0.24%)	1	0/38 (0.00%)	0
Syncope vasovagal ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Tachycardia ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Urinary tract infection ^† 1	0/191 (0.00%)	0	2/419 (0.48%)	2	0/38 (0.00%)	0
Abdominal abscess ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Abdominal discomfort ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Abdominal pain upper ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Acute coronary syndrome ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Adverse drug reaction ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Ankle fracture ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Anorexia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Anxiety disorder ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Aortic thrombosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arrhythmia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arterial disorder ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arterial stenosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arteriogram coronary ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arteriopathic disease ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Arthralgia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Asthenia ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Bacteraemia ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Balance disorder ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Biopsy liver ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Bronchopulmonary aspergillosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cardiac ablation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cardiac failure ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cardiac procedure complication ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Cardio-renal syndrome ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cardiomyopathy ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cardiomyopathy alcoholic ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cellulitis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Cervical dysplasia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Chest discomfort ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Colon cancer ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Colonic obstruction ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Colostomy ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Constipation ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Contrast media reaction ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Convulsion ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Coronary artery restenosis ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Decreased RV Sensing ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Depressed level of consciousness ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Device electrical finding ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Device migration ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Device related infection ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Diabetes mellitus insulin-dependent ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Dislodgement of LV lead ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Diverticulitis esophageal ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Duodenal ulcer ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Edema peripheral ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Elevated pacing threshold ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Endocarditis ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Epistaxis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Extrasystoles ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Fluid overload ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Gastroenteritis ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
General physical health deterioration ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Goiter ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Hairy cell leukemia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Headache ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hematoma evacuation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hemianopsia homonymous ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Hemoglobin decreased ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Hemorrhage ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hemorrhoids ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hepatic function abnormal ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hip arthroplasty ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypersensitivity ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hyperthyroidism ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypervolemic ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypoglycemia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypokalemia ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Hyponatremia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypothyroidism ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Hypoxia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Implant site erosion ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Implant site inflammation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Implant site irritation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
In-stent arterial restenosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Incision site complication ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Infection ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Inguinal hernia repair ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Intermittent claudication ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Intestinal obstruction ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Iodine allergy ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Joint dislocation ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Joint swelling ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Knee arthroplasty ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Leukothrombopenia ^† 1	0/191 (0.00%)	0	0/419 (0.00%)	0	1/38 (2.63%)	1
Low cardiac output syndrome ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Lower respiratory tract infection ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Lower respiratory tract infection viral ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Lumbar spinal stenosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Lung adenocarcinoma ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Lung consolidation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Malaise ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Medical device complication ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Melaena ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Metastases to bone ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Metastatic neoplasm ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Mitral valve disease ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Mitral valve repair ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Multi-organ failure ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Musculoskeletal chest pain ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Neoplasm malignant ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Nephrolithiasis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Nodal arrhythmia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Orthostatic intolerance ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Oxygen saturation decreased ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Palpitations ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Perianal abscess ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Peripheral arterial occlusive disease ^† 1	0/191 (0.00%)	0	0/419 (0.00%)	0	1/38 (2.63%)	1
Peripheral ischemia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Phlebitis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Pituitary tumor ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Pleural effusion ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Polyneuropathy ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Prostate cancer ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Pulmonary hypertension ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Pulmonary mass ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Rectal hemorrhage ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Renal cancer metastatic ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Renal impairment ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Retinal detachment ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Retroperitoneal hemorrhage ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Sinusitis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Sinusitis ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Skin irritation ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Skin ulcer ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Small cell lung cancer stage unspecified ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Small intestinal obstruction ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Spondylolysis ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Squamous cell carcinoma ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Subarachnoid hemorrhage ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Subdural hematoma ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Supraventricular tachycardia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Throat lesion ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Thrombocytopenia ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Tonsillar disorder ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Tooth disorder ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Twiddler's syndrome ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Urinary bladder adenoma ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Valvuloplasty cardiac ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Vascular pseudoaneurysm ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Venous stenosis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Ventricular arrhythmia ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Ventricular assist device insertion ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Vertigo CNS origin ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Vestibular neuronitis ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Viral infection ^† 1	1/191 (0.52%)	1	0/419 (0.00%)	0	0/38 (0.00%)	0
Vocal cord polyp ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Vocal cord thickening ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
Wound dehiscence ^† 1	0/191 (0.00%)	0	1/419 (0.24%)	1	0/38 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CRT OFF		CRT ON		Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	61/119 (51.26%)		140/491 (28.51%)		2/38 (5.26%)
General disorders
Cardiac failure chronic ^† 1	24/119 (20.17%)	30	31/491 (6.31%)	35	1/38 (2.63%)	1
Atrial fibrillation ^† 1	8/119 (6.72%)	8	47/491 (9.57%)	57	0/38 (0.00%)	0
Dizziness ^† 1	9/119 (7.56%)	9	25/491 (5.09%)	29	1/38 (2.63%)	1
Inappropriate device stimulation of tissue ^† 1	11/119 (9.24%)	12	21/491 (4.28%)	25	0/38 (0.00%)	0
Inappropriate device irritation of tissue ^† 1	4/119 (3.36%)	4	26/491 (5.30%)	30	1/38 (2.63%)	1
Hypotension ^† 1	10/119 (8.40%)	12	16/491 (3.26%)	16	0/38 (0.00%)	0
Fatigue ^† 1	12/119 (10.08%)	12	15/491 (3.05%)	15	0/38 (0.00%)	0
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

In most cases, contracts allow investigators to publish study results per the publication plan/protocol following Medtronic's review to determine whether confidential information ("CI") is disclosed. Any such CI is deleted prior to publication/presentation. Medtronic may not censor/interfere with the publication except as described. Investigators may not publish any single-site publications until the main multi-site study publication has occurred.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	CRDM Core Clinical
Organization:	Medtronic CRDM
Phone:	800-328-2518
EMail:	medtroniccrmtrials@medtronic.com

Publications of Results:

Linde C, Abraham WT, Gold MR, St John Sutton M, Ghio S, Daubert C; REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) Study Group. Randomized trial of cardiac resynchronization in mildly symptomatic heart failure patients and in asymptomatic patients with left ventricular dysfunction and previous heart failure symptoms. J Am Coll Cardiol. 2008 Dec 2;52(23):1834-1843. doi: 10.1016/j.jacc.2008.08.027. Epub 2008 Nov 7.

Linde C, Gold M, Abraham WT, Daubert JC; REVERSE Study Group. Baseline characteristics of patients randomized in The Resynchronization Reverses Remodeling In Systolic Left Ventricular Dysfunction (REVERSE) study. Congest Heart Fail. 2008 Mar-Apr;14(2):66-74.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gold MR, Rickard J, Daubert JC, Zimmerman P, Linde C. Redefining the Classifications of Response to Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2021 Jul;7(7):871-880. doi: 10.1016/j.jacep.2020.11.010. Epub 2021 Feb 24.

Senfield J, Daubert C, Abraham WT, Ghio S, St John Sutton M, Cerkvenik J, Linde C, Gold MR. The Impact of the PR Interval in Patients Receiving Cardiac Resynchronization Therapy: Results From the REVERSE Study. JACC Clin Electrophysiol. 2017 Aug;3(8):818-826. doi: 10.1016/j.jacep.2017.01.017. Epub 2017 Apr 26.

Linde C, Cleland JGF, Gold MR, Claude Daubert J, Tang ASL, Young JB, Sherfesee L, Abraham WT. The interaction of sex, height, and QRS duration on the effects of cardiac resynchronization therapy on morbidity and mortality: an individual-patient data meta-analysis. Eur J Heart Fail. 2018 Apr;20(4):780-791. doi: 10.1002/ejhf.1133. Epub 2018 Jan 4. Review.

Gold MR, Padhiar A, Mealing S, Sidhu MK, Tsintzos SI, Abraham WT. Economic Value and Cost-Effectiveness of Cardiac Resynchronization Therapy Among Patients With Mild Heart Failure: Projections From the REVERSE Long-Term Follow-Up. JACC Heart Fail. 2017 Mar;5(3):204-212. doi: 10.1016/j.jchf.2016.10.014. Epub 2017 Jan 11.

St John Sutton M, Linde C, Gold MR, Abraham WT, Ghio S, Cerkvenik J, Daubert JC; REVERSE Study Group. Left Ventricular Architecture, Long-Term Reverse Remodeling, and Clinical Outcome in Mild Heart Failure With Cardiac Resynchronization: Results From the REVERSE Trial. JACC Heart Fail. 2017 Mar;5(3):169-178. doi: 10.1016/j.jchf.2016.11.012.

St John Sutton M, Cerkvenik J, Borlaug BA, Daubert C, Gold MR, Ghio S, Chirinos JA, Linde C, Ky B. Effects of Cardiac Resynchronization Therapy on Cardiac Remodeling and Contractile Function: Results From Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE). J Am Heart Assoc. 2015 Sep 11;4(9):e002054. doi: 10.1161/JAHA.115.002054.

Gold MR, Daubert JC, Abraham WT, Hassager C, Dinerman JL, Hudnall JH, Cerkvenik J, Linde C. Implantable defibrillators improve survival in patients with mildly symptomatic heart failure receiving cardiac resynchronization therapy: analysis of the long-term follow-up of remodeling in systolic left ventricular dysfunction (REVERSE). Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1163-8. doi: 10.1161/CIRCEP.113.000570. Epub 2013 Oct 14.

Linde C, Daubert C, Abraham WT, St John Sutton M, Ghio S, Hassager C, Herre JM, Bergemann TL, Gold MR; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Impact of ejection fraction on the clinical response to cardiac resynchronization therapy in mild heart failure. Circ Heart Fail. 2013 Nov;6(6):1180-9. doi: 10.1161/CIRCHEARTFAILURE.113.000326. Epub 2013 Sep 6.

Cleland JG, Abraham WT, Linde C, Gold MR, Young JB, Claude Daubert J, Sherfesee L, Wells GA, Tang AS. An individual patient meta-analysis of five randomized trials assessing the effects of cardiac resynchronization therapy on morbidity and mortality in patients with symptomatic heart failure. Eur Heart J. 2013 Dec;34(46):3547-56. doi: 10.1093/eurheartj/eht290. Epub 2013 Jul 29. Review.

Linde C, Gold MR, Abraham WT, St John Sutton M, Ghio S, Cerkvenik J, Daubert C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction Study Group. Long-term impact of cardiac resynchronization therapy in mild heart failure: 5-year results from the REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) study. Eur Heart J. 2013 Sep;34(33):2592-9. doi: 10.1093/eurheartj/eht160. Epub 2013 May 2.

Gold MR, Thébault C, Linde C, Abraham WT, Gerritse B, Ghio S, St John Sutton M, Daubert JC. Effect of QRS duration and morphology on cardiac resynchronization therapy outcomes in mild heart failure: results from the Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction (REVERSE) study. Circulation. 2012 Aug 14;126(7):822-9. doi: 10.1161/CIRCULATIONAHA.112.097709. Epub 2012 Jul 10.

Thébault C, Donal E, Meunier C, Gervais R, Gerritse B, Gold MR, Abraham WT, Linde C, Daubert JC; REVERSE study group. Sites of left and right ventricular lead implantation and response to cardiac resynchronization therapy observations from the REVERSE trial. Eur Heart J. 2012 Nov;33(21):2662-71. doi: 10.1093/eurheartj/ehr505. Epub 2012 Jan 26.

Gold MR, Linde C, Abraham WT, Gardiwal A, Daubert JC. The impact of cardiac resynchronization therapy on the incidence of ventricular arrhythmias in mild heart failure. Heart Rhythm. 2011 May;8(5):679-84. doi: 10.1016/j.hrthm.2010.12.031. Epub 2010 Dec 23.

Linde C, Abraham WT, Gold MR, Daubert C; REVERSE Study Group. Cardiac resynchronization therapy in asymptomatic or mildly symptomatic heart failure patients in relation to etiology: results from the REVERSE (REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction) study. J Am Coll Cardiol. 2010 Nov 23;56(22):1826-31. doi: 10.1016/j.jacc.2010.05.055.

Linde C, Daubert C. Cardiac resynchronization therapy in patients with New York Heart Association class I and II heart failure: an approach to 2010. Circulation. 2010 Sep 7;122(10):1037-43. doi: 10.1161/CIRCULATIONAHA.109.923094. Review.

St John Sutton M, Ghio S, Plappert T, Tavazzi L, Scelsi L, Daubert C, Abraham WT, Gold MR, Hassager C, Herre JM, Linde C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group. Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation. 2009 Nov 10;120(19):1858-65. doi: 10.1161/CIRCULATIONAHA.108.818724. Epub 2009 Oct 26.

Daubert C, Gold MR, Abraham WT, Ghio S, Hassager C, Goode G, Szili-Török T, Linde C; REVERSE Study Group. Prevention of disease progression by cardiac resynchronization therapy in patients with asymptomatic or mildly symptomatic left ventricular dysfunction: insights from the European cohort of the REVERSE (Resynchronization Reverses Remodeling in Systolic Left Ventricular Dysfunction) trial. J Am Coll Cardiol. 2009 Nov 10;54(20):1837-46. doi: 10.1016/j.jacc.2009.08.011. Epub 2009 Oct 1.

Layout table for additonal information

Responsible Party:	Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:	NCT00271154
Other Study ID Numbers:	233
First Submitted:	December 21, 2005
First Posted:	December 30, 2005
Results First Submitted:	December 24, 2008
Results First Posted:	May 13, 2009
Last Update Posted:	January 30, 2012

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