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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00461734
Other study ID # PROTECT-PACE Version 4
Secondary ID
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


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
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