Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT) - Full Text View

Sponsor:	Biotronik, Inc.
Collaborator:	University of Zurich
Information provided by (Responsible Party):	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00683696

Purpose

The EchoCRT trial evaluates the effects of Cardiac Resynchronization Therapy (CRT) on mortality and morbidity of subjects with heart failure due to left ventricular systolic dysfunction, already receiving optimized HF medication, with a narrow QRS width (< 130 ms) and echocardiographic evidence of ventricular dyssynchrony.

Condition	Intervention	Phase
Heart Failure Ventricular Dyssynchrony	Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D)	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Echocardiography Guided Cardiac Resynchronization Therapy (EchoCRT)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

The primary efficacy endpoint will evaluate the effect of CRT=ON versus CRT=OFF in time to event of a combined endpoint of all-cause mortality or first hospitalization for worsening heart failure. [ Time Frame: Full study duration (event driven trial). Minimum 1 year follow-up and expected median patient follow-up duration of 2 years. ] [ Designated as safety issue: No ]
The primary safety endpoint will evaluate the complication-free rate of the Lumax HF-T CRT-D devices in the narrow QRS subject population. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluate the effects of CRT=ON compared to CRT=OFF on the rate of hospitalization for worsening heart failure. [ Time Frame: Full study duration ] [ Designated as safety issue: No ]
Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in NYHA classification. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluate the effects of CRT=ON compared to CRT=OFF in relation to the change in the Minnesota Living with Heart Failure (MLHF) Quality of Life Questionnaire. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Evaluate the effects of CRT=ON compared to CRT=OFF in relation to a composite endpoint of all-cause mortality, hospitalization for worsening heart failure and change in the MLHF Quality of Life Questionnaire. [ Time Frame: 2 years for death or hospitalization, 6 months for QOL evaluation ] [ Designated as safety issue: No ]
Evaluate the all-cause mortality rate between the CRT=ON compared to CRT=OFF group. [ Time Frame: Full study duration ] [ Designated as safety issue: No ]

Estimated Enrollment:	2330
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CRT=ON Cardiac Resynchronization Therapy activated.	Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF. Other Name: Lumax HF-T CRT-D system
Active Comparator: CRT=OFF Cardiac Resynchronization Therapy deactivated.	Device: Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (BIOTRONIK Lumax HF-T CRT-D) All patients will receive a commercially available BIOTRONIK Lumax HF-T CRT-D system with ICD back-up enabled. Patients will be randomized to CRT=ON or CRT=OFF. Other Name: Lumax HF-T CRT-D system

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women 18 years of age or older.
Understand the nature of the procedure.
Give written informed consent.
Willing and able to complete all testing required by the clinical protocol.
Indication for an implantable cardioverter defibrillator (ICD).
NYHA class III-IV within the last three months prior to enrollment and at baseline (at baseline only: also Stage C according to ACC/AHA guidelines).
Stable optimal pharmacologic therapy for HF.
An ejection fraction ≤ 35% within one year prior to enrollment and confirmed on the baseline echocardiogram.
Increased left ventricular dimension, defined as LVEDD ≥ 55 mm.
Resting QRS duration < 130 ms evidenced by a historical 12-lead ECG prior to enrollment and at baseline.
Ventricular dyssynchrony assessed by echocardiography locally and confirmed by the echo core lab. One of the two following criteria has to be present to include the subject in the study:
- Intra-left ventricular dyssynchrony measured by color Tissue Doppler Imaging (TDI) with an opposing wall delay of ≥ 80 ms in the 4-chamber or apical long-axis view.
- Speckle-tracking radial strain septal-posterior wall delay ≥ 130 ms.

Exclusion Criteria:

Implanted pacemaker or defibrillator with >10% ventricular pacing, as demonstrated by device statistics averaged over at least the last three months prior to enrollment.
Women who are pregnant, lactating, or planning to become pregnant during the course of the trial.
Bradycardia pacing indication.
Surgically correctable primary valvular heart disease, i.e. aortic stenosis, torn cordae, or flail segment.
Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past 3 months prior to enrollment.
Enzyme-positive myocardial infarction within the past 3 months prior to enrollment.
Angiographic evidence of coronary disease, candidates for coronary revascularization likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the next 3 months.
Irreversible brain damage from preexisting cerebral disease.
Reversible non-ischemic cardiomyopathy such as acute viral myocarditis.
Permanent second or third degree heart block.
Chagas disease.
Persistent or paroxysmal atrial fibrillation within one month prior to enrollment.
Expected to receive heart transplantation within six months.
Current inotropic therapy.
Acutely decompensated heart failure.
Contrast dye allergy and unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
Life expectancy of less than six months.
Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer).
Significant renal insufficiency defined as a serum creatinine > 2.5 mg/dL (> 221 µmol/L) within the last four weeks prior to enrollment..
Liver failure, defined as three times the upper limit of normal for aminotransferases.
Participation in any other clinical trial.
Unable to return for follow-up visits due to distance from the clinic.
Do not anticipate being a resident of the area for the scheduled duration of the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683696

Contacts

Contact: Amy Bartonek

+1-800- 547- 0394 ext 8034

amy.bartonek@biotronik.com

Show 95 Study Locations

Sponsors and Collaborators

Biotronik, Inc.

University of Zurich

Investigators

Study Chair:	Frank Ruschitzka, MD	University of Zurich, Switzerland
Study Chair:	Johannes Holzmeister, MD	University of Zurich, Switzerland
Principal Investigator:	William Abraham, MD	Principal Investigator (USA) at The Ohio State University, OH, USA

More Information

No publications provided

Responsible Party:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00683696 History of Changes
Other Study ID Numbers:	EchoCRT
Study First Received:	August 30, 2007
Last Updated:	December 1, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biotronik, Inc.:

Cardiac Resynchronization Therapy
Heart Failure
Ventricular Dyssynchrony
Mechanical Dyssynchrony
Intraventricular Dyssynchrony

Echocardiography
Normal QRS
Heart Disease
EchoCRT

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2012