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

NCT00461734 | Completed Results

• 1 other identifier: PROTECT-PACE Version 4
• Study Type: interventional
• Target: 248
• Locations: 3 countries
• Sites: 18

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.

Conditions

Left Ventricular Dysfunction

Keywords

Right Ventricular High Septal Pacing; Right Ventricular Apical Pacing; Left Ventricular Dysfunction; Heart Block; Pacemaker; Atrial Fibrillation; Ejection Fraction

Outcome Measures

Primary Outcomes (2)

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

  At 2-year follow-up

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

  At 2-year follow-up

Secondary Outcomes (12)

• Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)

  At 2-year follow-up

• Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)

  At 2-year follow-up

• Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)

  At 5-years follow-up (study extension)

• Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)

  At 5-year follow-up (study extension)

• Worsening of Heart Failure

  At 5-year follow-up (study extension)

Study Arms (2)

RV Apex

ACTIVE COMPARATOR

Other: RV lead placement site

RV High Septum

EXPERIMENTAL

Other: RV lead placement site

Interventions

RV lead placement site OTHER

Patients randomised to RV apical or high septal lead placement site

RV Apex; RV High Septum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (18)

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Location

Royal Brisbane & Womens' Hospital

Brisbane, Queensland, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, Australia

Location

Calvary Wakefield Hospital

Adelaide, South Australia, Australia

Location

Flinders Medical Center

Adelaide, South Australia, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

Auckland City Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Blackpool Victoria Hospital

Blackpool, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Location

University Hospital of Wales

Cardiff, United Kingdom

Location

Colchester General

Colchester, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, United Kingdom

Location

Princess Royal Hospital

Orpington, Kent, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 26517949 DERIVED

• 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.

  PMID: 25862716 DERIVED

• 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.

  PMID: 25666325 DERIVED

• 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.

  PMID: 25189602 DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Heart Block; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Gerald Kaye
• Organization: Princess Alexandra Hospital

gerald.kaye@health.qld.gov.au

07 3176 2111

Study Officials

• Dr. Gerald Kaye

  Princess Alexandra Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: August 1, 2007
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2015
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2); AU (6); GB (10)