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

Left Ventricular Dysfunction Clinical Trial

— 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?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00461734
• Other study ID #: PROTECT-PACE Version 4
• Status: Active, not recruiting
• Phase: N/A
• First received: April 17, 2007
• Last updated: May 14, 2012
• Start date: May 2007
• Est. completion date: August 2015

Study information

• Verified date: May 2012
• Source: Medtronic Cardiac Rhythm Disease Management
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeAustralia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: August 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Left Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Other:
• RV lead placement site
Patients randomised to RV apical or high septal lead placement site

Locations

Country	Name	City	State
Australia	Calvary Wakefield Hospital	Adelaide	South Australia
Australia	Flinders Medical Center	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Princess Alexandra Hospital	Brisbane	Queensland
Australia	Royal Brisbane & Womens' Hospital	Brisbane	Queensland
Australia	The Prince Charles Hospital	Brisbane	Queensland
New Zealand	Auckland City Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Australia,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of change in Left Ventricular Ejection Fraction from baseline to 2 years.		At 2-year follow-up	No
Secondary	Incidence of atrial tachyarrhythmia recorded by the pacemakers		At 2-year follow-up; and at 5-year follow-up (study extension)	No
Secondary	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.	At 2-year follow-up; and at 5-year follow-up (study extension)	No
Secondary	All cause mortality		At 2-year follow-up; and at 5-year follow-up (study extension)	No
Secondary	Incidence of stroke		At 2-year follow-up	No
Secondary	N-Terminal Brain Natriuretic Peptide (NT-proBNP) levels		At 2-year follow-up	No
Secondary	Echocardiographic measures of left ventricular dyssynchrony		At 2-year follow-up	No
Secondary	6 minute Hall-Walk distance		At 2-year follow-up	No