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

Primary Purpose

Left Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
RV lead placement site
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Left Ventricular Dysfunction focused on measuring Right Ventricular High Septal Pacing, Right Ventricular Apical Pacing, Left Ventricular Dysfunction, Heart Block, Pacemaker, Atrial Fibrillation, Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with high grade AV block and sinus rhythm, scheduled to undergo dual chamber pacemaker implantation OR patients with high grade AV block and permanent atrial fibrillation, scheduled to undergo single chamber ventricular pacemaker implantation.
  • Patients aged 18 years or older.

Exclusion Criteria:

  • Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
  • Patients following junctional ablation.
  • Patients with a Myocardial Infarction within three months prior to enrollment.
  • Patients that received bypass surgery within three months prior to enrollment.
  • Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve.
  • Patients where a right ventricular lead cannot be placed i.e. complex congenital heart disease.
  • Patients with hypertrophic obstructive cardiomyopathy.
  • Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or hemodynamically significant aortic stenosis.
  • Previous implanted pacemaker or cardioverter defibrillator.
  • Known paroxysmal atrial fibrillation or a documented episode of atrial fibrillation prior to enrollment.
  • Patients on amiodarone therapy within the last six months prior to enrollment.
  • Terminal conditions with a life expectancy of less than two years.
  • Participation in any other study that would confound the results of this study.
  • Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study.
  • Pregnant patients or patients who may become pregnant during the time-scale of the study.

Sites / Locations

  • Princess Alexandra Hospital
  • Royal Brisbane & Womens' Hospital
  • The Prince Charles Hospital
  • Calvary Wakefield Hospital
  • Flinders Medical Center
  • Royal Adelaide Hospital
  • Auckland City Hospital
  • Christchurch Hospital
  • Blackpool Victoria Hospital
  • Royal Bournemouth Hospital
  • University Hospital of Wales
  • Colchester General
  • Leeds General Infirmary
  • St. Thomas' Hospital
  • James Cook University Hospital
  • Norfolk and Norwich University Hospital
  • Princess Royal Hospital
  • New Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RV Apex

RV High Septum

Arm Description

Outcomes

Primary Outcome Measures

Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).

Secondary Outcome Measures

Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Worsening of Heart Failure
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.
All Cause Mortality
Incidence of Stroke
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Echocardiographic Measures of Left Ventricular Dyssynchrony
No analysis has been done for this section since that variable was not collected during the study.
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
6 Minute Hall-Walk Distance (Per Protocol Cohort)

Full Information

First Posted
April 17, 2007
Last Updated
March 14, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT00461734
Brief Title
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Acronym
PROTECT-PACE
Official Title
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing. Does Right Ventricular High-septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering pulses of electricity through special wires (pacing leads) which are placed inside the heart. This study will compare two groups of pacemaker patients. Each group will have their pacing leads placed in a particular location in the heart. The purpose of the study is to show whether the position used in one group is better for maintaining effective heart function compared to the position used in the other group. The leads in one group will be placed in a position called the Right Ventricular Apex. This is the traditional and most frequently used position for pacemaker leads. The leads in the other group will be placed in a position called the Right Ventricular High Septum. This is a less commonly used position, but may result in health benefits for the patients compared with the Right Ventricular Apex.
Detailed Description
There is an increasing amount of evidence to suggest that other positions in the heart may be more effective than the conventional Right Ventricular Apex (RVA) position for restoring good heart function. The best site to place a lead has not yet been proven. This is a study comparing the long term clinical effects of two different lead positions. The measurements taken to assess the clinical effects include: the effectiveness of the heart's pumping action (as measured by ultrasound scans) measurements of how far patients can walk in 6 minutes analysis of blood samples collection of information from the pacemaker about heart rhythm problems Half of the patients in the study will receive conventional leads placed in the more common RVA position in the heart. The other half will receive a relatively new type of lead placed in what is called the Right Ventricular High Septal (RVHS) position. In order to fairly compare the outcomes of these two different lead positions this study has been designed as a 'randomized', 'blind' trial. This means that the group which patients will be entered into will be chosen at random and patients will not be told which group they are in. Patients will each have an equal (50:50) chance of being in either group. By carefully comparing the clinical differences between the two groups of patients, the study aims to prove whether or not there are additional benefits for patients when the RVHS lead position is used. All leads used in the study have been shown to be safe for patients and are available commercially for implantation. All of the implanting doctors involved in the study are experienced at implanting the pacemakers and leads that will be used in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction
Keywords
Right Ventricular High Septal Pacing, Right Ventricular Apical Pacing, Left Ventricular Dysfunction, Heart Block, Pacemaker, Atrial Fibrillation, Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RV Apex
Arm Type
Active Comparator
Arm Title
RV High Septum
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
RV lead placement site
Intervention Description
Patients randomised to RV apical or high septal lead placement site
Primary Outcome Measure Information:
Title
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
Time Frame
At 2-year follow-up
Title
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
Time Frame
At 2-year follow-up
Secondary Outcome Measure Information:
Title
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Time Frame
At 2-year follow-up
Title
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Time Frame
At 2-year follow-up
Title
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)
Time Frame
At 5-years follow-up (study extension)
Title
Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)
Time Frame
At 5-year follow-up (study extension)
Title
Worsening of Heart Failure
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)
Title
All Cause Mortality
Time Frame
At 5-year follow-up (study extension)
Title
Incidence of Stroke
Time Frame
At 5-year follow-up (study extension)
Title
Brain Natriuretic Peptide Levels (Intent to Treat Cohort)
Time Frame
At 2-year follow-up
Title
Brain Natriuretic Peptide Levels (Per Protocol Cohort)
Time Frame
At 2-year follow-up
Title
Echocardiographic Measures of Left Ventricular Dyssynchrony
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
Title
6 Minute Hall-Walk Distance (Intent to Treat Cohort)
Time Frame
At 2-year follow-up
Title
6 Minute Hall-Walk Distance (Per Protocol Cohort)
Time Frame
At 2-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with high grade AV block and sinus rhythm, scheduled to undergo dual chamber pacemaker implantation OR patients with high grade AV block and permanent atrial fibrillation, scheduled to undergo single chamber ventricular pacemaker implantation. Patients aged 18 years or older. Exclusion Criteria: Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy. Patients following junctional ablation. Patients with a Myocardial Infarction within three months prior to enrollment. Patients that received bypass surgery within three months prior to enrollment. Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve. Patients where a right ventricular lead cannot be placed i.e. complex congenital heart disease. Patients with hypertrophic obstructive cardiomyopathy. Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or hemodynamically significant aortic stenosis. Previous implanted pacemaker or cardioverter defibrillator. Known paroxysmal atrial fibrillation or a documented episode of atrial fibrillation prior to enrollment. Patients on amiodarone therapy within the last six months prior to enrollment. Terminal conditions with a life expectancy of less than two years. Participation in any other study that would confound the results of this study. Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study. Pregnant patients or patients who may become pregnant during the time-scale of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Gerald Kaye
Organizational Affiliation
Princess Alexandra Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Brisbane & Womens' Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Calvary Wakefield Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Flinders Medical Center
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Blackpool Victoria Hospital
City
Blackpool
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Colchester General
City
Colchester
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
Facility Name
St. Thomas' Hospital
City
London
Country
United Kingdom
Facility Name
James Cook University Hospital
City
Middlesbrough
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Facility Name
Princess Royal Hospital
City
Orpington, Kent
Country
United Kingdom
Facility Name
New Cross Hospital
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26517949
Citation
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.
Results Reference
derived
PubMed Identifier
25862716
Citation
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.
Results Reference
derived
PubMed Identifier
25666325
Citation
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.
Results Reference
derived
PubMed Identifier
25189602
Citation
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.
Results Reference
derived

Learn more about this trial

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

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