PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing (PROTECT-PACE)

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ClinicalTrials.gov Identifier: NCT00461734

Recruitment Status : Completed

First Posted : April 18, 2007

Results First Posted : April 25, 2017

Last Update Posted : April 25, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm and Heart Failure

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition	Left Ventricular Dysfunction
Intervention	Other: RV lead placement site
Enrollment	248

Participant Flow

Recruitment Details

Pre-assignment Details

Partecipants initially assessed for eligibility were 248 of whom 8 were excluded before the randomization due to the following causes:

4 failed inclusion/exclusion criteria
2 cheanged medical condition resulting no longer eligible
1 had a non-pacemaker procedure
1 the site was aware of his/her randomization code in the envelope


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description	RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site
Period Title: Overall Study
Started	120	120
Completed	62	60
Not Completed	58	60

Baseline Characteristics

Arm/Group Title		RV Apex	RV High Septum	Total
Arm/Group Description		RV lead placement site: Patients ra...	RV lead placement site: Patients ra...	Total of all reporting groups
Arm/Group Description		RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site	Total of all reporting groups
Overall Number of Baseline Participants		120	120	240
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	120 participants	120 participants	240 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	25 20.8%	19 15.8%	44 18.3%
	>=65 years	95 79.2%	101 84.2%	196 81.7%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	120 participants	120 participants	240 participants
		73.7 (11.1)	74.7 (10)	74.2 (10.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	120 participants	120 participants	240 participants
	Female	47 39.2%	32 26.7%	79 32.9%
	Male	73 60.8%	88 73.3%	161 67.1%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	120 participants	120 participants	240 participants
New Zealand		12	14	26
United Kingdom		44	42	86
Australia		64	64	128

Outcome Measures

1.Primary Outcome


Title	Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Intent to Treat Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)	RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed	88	88
Mean (Standard Deviation) Unit of Measure: percentage
	-2.29 (10.5)	-3.43 (8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.4347
	Comments	[Not Specified]
	Method	two-sided z-test
	Comments	[Not Specified]

2.Primary Outcome


Title	Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Per Protocol Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ef...	RV lead placement site: Patients ef...
Arm/Group Description:	RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)	RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed	89	59
Mean (Standard Deviation) Unit of Measure: percentage
	-2.04 (10.4)	-3.60 (7.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.338
	Comments	[Not Specified]
	Method	two-sided z-test
	Comments	[Not Specified]

3.Secondary Outcome


Title	Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Intent to Treat Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)	RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed	90	96
Mean (Standard Deviation) Unit of Measure: minutes per day
	56.47 (22.61)	24.11 (14.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.2257
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

4.Secondary Outcome


Title	Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Per Protocol Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ef...	RV lead placement site: Patients ef...
Arm/Group Description:	RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)	RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed	98	60
Mean (Standard Deviation) Unit of Measure: minutes per day
	40.98 (20.04)	6.66 (4.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.5480
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

5.Secondary Outcome


Title	Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 5-years follow-up (study extension)

Outcome Measure Data

Analysis Population Description

Intent to Treat Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)	RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed	50	58
Mean (Standard Deviation) Unit of Measure: minutes per day
	17.73 (11.95)	63.83 (36.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8868
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

6.Secondary Outcome


Title	Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 5-year follow-up (study extension)

Outcome Measure Data

Analysis Population Description

Per Protocol Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ef...	RV lead placement site: Patients ef...
Arm/Group Description:	RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)	RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed	59	32
Mean (Standard Deviation) Unit of Measure: minutes per day
	62.75 (36.21)	18.61 (16.61)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.6151
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

7.Secondary Outcome


Title	Worsening of Heart Failure
Description	Worsening of heart failure can be defined as: ...
Description	Worsening of heart failure can be defined as: Heart failure-related hospitalization requiring intravenous heart failure therapy, or Emergency department visit for heart failure requiring intravenous heart failure therapy, or Any other visit in which the patient presents with signs or symptoms consistent with heart failure or heart failure exacerbation or marked decline in ejection fraction <35%, and intravenous heart failure therapy is required or titrate therapy. CRT-P or CRT-D upgrade.
Time Frame	At 5-year follow-up (study extension)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed	78	81
Measure Type: Number Unit of Measure: episodes
	19	17

8.Secondary Outcome


Title	All Cause Mortality
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 5-year follow-up (study extension)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed	78	81
Measure Type: Number Unit of Measure: participants
	14	11

9.Secondary Outcome


Title	Incidence of Stroke
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 5-year follow-up (study extension)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed	78	81
Measure Type: Number Unit of Measure: participants
	5	6

10.Secondary Outcome


Title	Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Intent to Treat Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)	RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to trat cohort)
Overall Number of Participants Analyzed	72	71
Median (Full Range) Unit of Measure: picograms per milliliter
	138.2 (0.3 to 1428)	111.3 (0.3 to 1536)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0525
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

11.Secondary Outcome


Title	Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Per Protocol Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ef...	RV lead placement site: Patients ef...
Arm/Group Description:	RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)	RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed	72	48
Median (Full Range) Unit of Measure: picograms per milliliter
	176.6 (0.3 to 1428)	110.8 (0.3 to 1429)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1852
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

12.Secondary Outcome


Title	Echocardiographic Measures of Left Ventricular Dyssynchrony
Description	No analysis has been done for this section since that variable was not...
Description	No analysis has been done for this section since that variable was not collected during the study.
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

No analysis has been done for this section since that variable was not collected during the study


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site	RV lead placement site: Patients randomised to RV high septal lead placement site
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

13.Secondary Outcome


Title	6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Intent to Treat Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ra...	RV lead placement site: Patients ra...
Arm/Group Description:	RV lead placement site: Patients randomised to RV apical lead placement site (Intent to treat cohort)	RV lead placement site: Patients randomised to RV high septal lead placement site (Intent to treat cohort)
Overall Number of Participants Analyzed	67	68
Median (Inter-Quartile Range) Unit of Measure: meters
	391 (307 to 475)	395 (320 to 463.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.9719
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

14.Secondary Outcome


Title	6 Minute Hall-Walk Distance (Per Protocol Cohort)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	At 2-year follow-up

Outcome Measure Data

Analysis Population Description

Per Protocol Cohort with data available


Arm/Group Title	RV Apex	RV High Septum
Arm/Group Description:	RV lead placement site: Patients ef...	RV lead placement site: Patients ef...
Arm/Group Description:	RV lead placement site: Patients effectively had RV apical lead placement site (Per protocol cohort)	RV lead placement site: Patients effectively had RV high septal lead placement site (Per protocol cohort)
Overall Number of Participants Analyzed	68	47
Median (Inter-Quartile Range) Unit of Measure: meters
	385.5 (304.5 to 477.5)	426.5 (355.5 to 480)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	RV Apex, RV High Septum
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8779
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	[Not Specified]

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	RV Apex		RV High Septum
Arm/Group Description	RV lead placement site: Patients ra...		RV lead placement site: Patients ra...
Arm/Group Description	RV lead placement site: Patients randomised to RV apical lead placement site		RV lead placement site: Patients randomised to RV high septal lead placement site
All-Cause Mortality
	RV Apex		RV High Septum
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	RV Apex		RV High Septum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	78/120 (65.00%)		81/120 (67.50%)
Blood and lymphatic system disorders
anemia ^* 1	3/120 (2.50%)	3	3/120 (2.50%)	3
Cardiac disorders
SOB ^* 1	25/120 (20.83%)	34	29/120 (24.17%)	50
product issue ^* 1 [1]	9/120 (7.50%)	9	11/120 (9.17%)	15
Endocrine disorders
diabets ^* 1	1/120 (0.83%)	1	2/120 (1.67%)	3
Gastrointestinal disorders
rectal bleeding ^* 1	11/120 (9.17%)	12	7/120 (5.83%)	7
General disorders
chest pain ^* 1	10/120 (8.33%)	13	9/120 (7.50%)	9
death ^* 1	19/120 (15.83%)	19	16/120 (13.33%)	16
Hepatobiliary disorders
bile duct ^* 1	2/120 (1.67%)	3	2/120 (1.67%)	2
Infections and infestations
infection ^* 1	3/120 (2.50%)	3	1/120 (0.83%)	1
Injury, poisoning and procedural complications
trauma ^* 1	10/120 (8.33%)	10	20/120 (16.67%)	23
Investigations
angiography ^* 1	2/120 (1.67%)	2	1/120 (0.83%)	1
Metabolism and nutrition disorders
dehydration ^* 1	0/120 (0.00%)	0	1/120 (0.83%)	2
Musculoskeletal and connective tissue disorders
arthritis ^* 1	6/120 (5.00%)	9	6/120 (5.00%)	6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
carcinoma ^* 1	8/120 (6.67%)	10	8/120 (6.67%)	15
Nervous system disorders
stroke ^* 1	4/120 (3.33%)	8	9/120 (7.50%)	12
Renal and urinary disorders
urinary tract infection ^* 1	5/120 (4.17%)	5	3/120 (2.50%)	3
Reproductive system and breast disorders
prostate ^* 1	1/120 (0.83%)	1	2/120 (1.67%)	2
Respiratory, thoracic and mediastinal disorders
pneumonia ^* 1	9/120 (7.50%)	11	8/120 (6.67%)	10
Skin and subcutaneous tissue disorders
dermatitis ^* 1	2/120 (1.67%)	2	1/120 (0.83%)	1
Surgical and medical procedures
bypass ^* 1	7/120 (5.83%)	10	5/120 (4.17%)	5
Vascular disorders
raynaud's disease ^* 1	11/120 (9.17%)	12	8/120 (6.67%)	13
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 19.0 [1] Adverse events related to the pacemaker (e.g., lead dislodgment or changing in threshold values). The term 'product issue' is taken from MedDRA 19.0 classification.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	RV Apex		RV High Septum
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/120 (5.00%)		0/120 (0.00%)
Musculoskeletal and connective tissue disorders
musculoskeletal pain ^* 1	6/120 (5.00%)	6	0/120 (0.00%)	0
* Indicates events were collected by non-systematic assessment 1 Term from vocabulary, MedDRA 19.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Gerald Kaye
Organization:	Princess Alexandra Hospital
Phone:	07 3176 2111
EMail:	gerald.kaye@health.qld.gov.au

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

Saito M, Iannaccone A, Kaye G, Negishi K, Kosmala W, Marwick TH; PROTECT-PACE investigators. Effect of Right Ventricular Pacing on Right Ventricular Mechanics and Tricuspid Regurgitation in Patients With High-Grade Atrioventricular Block and Sinus Rhythm (from the Protection of Left Ventricular Function During Right Ventricular Pacing Study). Am J Cardiol. 2015 Dec 15;116(12):1875-82. doi: 10.1016/j.amjcard.2015.09.041. Epub 2015 Oct 9.

Kosmala W, Saito M, Kaye G, Negishi K, Linker N, Gammage M, Marwick TH; Protect-Pace Investigators. Incremental value of left atrial structural and functional characteristics for prediction of atrial fibrillation in patients receiving cardiac pacing. Circ Cardiovasc Imaging. 2015 Apr;8(4):e002942. doi: 10.1161/CIRCIMAGING.114.002942.

Saito M, Kaye G, Negishi K, Linker N, Gammage M, Kosmala W, Marwick TH; Protect-Pace investigators. Dyssynchrony, contraction efficiency and regional function with apical and non-apical RV pacing. Heart. 2015 Apr;101(8):600-8. doi: 10.1136/heartjnl-2014-306990. Epub 2015 Feb 9.

Kaye GC, Linker NJ, Marwick TH, Pollock L, Graham L, Pouliot E, Poloniecki J, Gammage M; Protect-Pace trial investigators. Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study. Eur Heart J. 2015 Apr 7;36(14):856-62. doi: 10.1093/eurheartj/ehu304. Epub 2014 Sep 4.

Layout table for additonal information

Responsible Party:	Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:	NCT00461734
Other Study ID Numbers:	PROTECT-PACE Version 4
First Submitted:	April 17, 2007
First Posted:	April 18, 2007
Results First Submitted:	September 15, 2016
Results First Posted:	April 25, 2017
Last Update Posted:	April 25, 2017

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