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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461734
First Posted: April 18, 2007
Last Update Posted: April 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  Purpose

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.


Condition Intervention
Left Ventricular Dysfunction Other: RV lead placement site

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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?

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). [ Time Frame: At 2-year follow-up ]
  • Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort). [ Time Frame: At 2-year follow-up ]

Secondary Outcome Measures:
  • Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) [ Time Frame: At 2-year follow-up ]
  • Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) [ Time Frame: At 2-year follow-up ]
  • Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) [ Time Frame: At 5-years follow-up (study extension) ]
  • Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) [ Time Frame: At 5-year follow-up (study extension) ]
  • Worsening of Heart Failure [ Time Frame: At 5-year follow-up (study extension) ]

    Worsening of heart failure can be defined as:

    1. Heart failure-related hospitalization requiring intravenous heart failure therapy, or
    2. Emergency department visit for heart failure requiring intravenous heart failure therapy, or
    3. 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.
    4. CRT-P or CRT-D upgrade.

  • All Cause Mortality [ Time Frame: At 5-year follow-up (study extension) ]
  • Incidence of Stroke [ Time Frame: At 5-year follow-up (study extension) ]
  • Brain Natriuretic Peptide Levels (Intent to Treat Cohort) [ Time Frame: At 2-year follow-up ]
  • Brain Natriuretic Peptide Levels (Per Protocol Cohort) [ Time Frame: At 2-year follow-up ]
  • Echocardiographic Measures of Left Ventricular Dyssynchrony [ Time Frame: At 2-year follow-up ]
    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) [ Time Frame: At 2-year follow-up ]
  • 6 Minute Hall-Walk Distance (Per Protocol Cohort) [ Time Frame: At 2-year follow-up ]

Enrollment: 248
Study Start Date: August 2007
Study Completion Date: September 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RV Apex Other: RV lead placement site
Patients randomised to RV apical or high septal lead placement site
Experimental: RV High Septum Other: RV lead placement site
Patients randomised to RV apical or high septal lead placement site

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461734


Locations
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Royal Brisbane & Womens' Hospital
Brisbane, Queensland, Australia
The Prince Charles Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Calvary Wakefield Hospital
Adelaide, South Australia, Australia
Flinders Medical Center
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
New Zealand
Auckland City Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
Colchester General
Colchester, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
St. Thomas' Hospital
London, United Kingdom
James Cook University Hospital
Middlesbrough, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom
Princess Royal Hospital
Orpington, Kent, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: Dr. Gerald Kaye Princess Alexandra Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00461734     History of Changes
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
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Right Ventricular High Septal Pacing
Right Ventricular Apical Pacing
Left Ventricular Dysfunction
Heart Block
Pacemaker
Atrial Fibrillation
Ejection Fraction

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases