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

Sponsored by:	Medtronic Cardiac Rhythm Disease Management
Information provided by:	Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:	NCT00461734

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

Genetics Home Reference related topics: familial atrial fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
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 Disease Management:

Primary Outcome Measures:

Comparison of change in Left Ventricular Ejection Fraction between the two patient groups. [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of atrial tachyarrhythmia recorded by the pacemakers [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
Worsening of heart failure [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
Incidence of stroke [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
N-Terminal Brain Natriuretic Peptide (NT-proBNP) levels [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
Echocardiographic measures of left ventricular dyssynchrony [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]
6 minute Hall-Walk distance [ Time Frame: At 2-year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	238
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RV Apex: Active Comparator	Other: RV lead placement site Patients randomised to RV apical or high septal lead placement site
RV High Septum: Experimental	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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461734

Contacts

Contact: Natalie Middleton Middleton

natalie.middleton@medtronic.com

Locations

Australia, Queensland
The Prince Charles Hospital	Recruiting
Brisbane, Queensland, Australia
Contact: Steve Graves 07 3139 4711
Principal Investigator: Russell Denman
Royal Brisbane & Womens' Hospital	Recruiting
Brisbane, Queensland, Australia
Contact: Leeanne Palethorpe 07 3636 5281
Principal Investigator: Paul Martin
Princess Alexandra Hospital	Recruiting
Brisbane, Queensland, Australia
Contact: Cindy Hall 07 3240 7676
Principal Investigator: Gerald Kaye
Australia, South Australia
Royal Adelaide Hospital	Recruiting
Adelaide, South Australia, Australia
Contact: Vanessa Maxwell 08 8222 5789
Principal Investigator: Glenn Young
Calvary Wakefield Hospital	Recruiting
Adelaide, South Australia, Australia
Contact: AnneMarie Mitchell 08 82234288
Principal Investigator: Glenn Young
Flinders Medical Center	Recruiting
Adelaide, South Australia, Australia
Contact: Bel Vuljanic 08 8404 2007
Principal Investigator: Andrew McGavigan
New Zealand
Auckland City Hospital	Recruiting
Auckland, New Zealand
Contact: Kelly Reynish +64 9 630 9923
Principal Investigator: Nigel Lever
Christchurch Hospital	Recruiting
Christchurch, New Zealand
Contact: Bronwyn Davies +64 3 3641096
Principal Investigator: Ian Crozier
United Kingdom
James Cook University Hospital	Recruiting
Middlesbrough, United Kingdom
Principal Investigator: Dr. Nick Linker
Norfolk and Norwich University Hospital	Recruiting
Norwich, United Kingdom
Principal Investigator: Dr. Ian Williams
Leeds General Infirmary	Recruiting
Leeds, United Kingdom
Principal Investigator: Dr. Chris Pepper
Princess Royal Hospital	Recruiting
Orpington, Kent, United Kingdom
Principal Investigator: Dr. Steve Sutcliffe
St. Thomas' Hospital	Recruiting
London, United Kingdom
Principal Investigator: Dr. Aldo Rinaldi
University Hospital of Wales	Recruiting
Cardiff, United Kingdom
Principal Investigator: Dr. Zaheer Yousef
New Cross Hospital	Recruiting
Wolverhampton, United Kingdom
Principal Investigator: Dr. Rajpal Singh
Blackpool Victoria Hospital	Recruiting
Blackpool, United Kingdom
Principal Investigator: Dr. Graham Goode
Colchester General	Recruiting
Colchester, United Kingdom
Principal Investigator: Dr. Kare Tang
Royal Bournemouth Hospital	Recruiting
Bournemouth, United Kingdom
Principal Investigator: Dr. Adrian Rozkovec

Sponsors and Collaborators

Medtronic Cardiac Rhythm Disease Management

Investigators

Study Chair:

Dr. Gerald Kaye

Princess Alexandra Hospital

More Information

No publications provided

Responsible Party:	Medtronic UK Ltd ( Medtronic UK Ltd )
Study ID Numbers:	PROTECT-PACE Version 2
Study First Received:	April 17, 2007
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00461734 History of Changes
Health Authority:	United Kingdom: National Health Service; United Kingdom: Research Ethics Committee; Australia: Human Research Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe

Keywords provided by Medtronic Cardiac Rhythm Disease Management:

Right Ventricular High Septal Pacing
Right Ventricular Apical Pacing
Left Ventricular Dysfunction
Heart Block

Pacemaker
Atrial Fibrillation
Ejection Fraction

Study placed in the following topic categories:

Ventricular Dysfunction
Heart Diseases
Heart Block
Ventricular Dysfunction, Left
Atrial Fibrillation

Additional relevant MeSH terms:

Ventricular Dysfunction
Heart Diseases
Ventricular Dysfunction, Left
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009