Full Text View
Tabular View
No Study Results Posted
Related Studies
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
This study is currently recruiting participants.
Study NCT00461734   Information provided by Medtronic Cardiac Rhythm Disease Management
First Received: April 17, 2007   Last Updated: April 23, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

April 17, 2007
April 23, 2009
May 2007
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 ]
Same as current
Complete list of historical versions of study NCT00461734 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of atrial tachyarrhythmia recorded by the pacemakers at 1 and 2 years
  • Worsening of heart failure at 1 and 2 years
  • All cause mortality at 1 and 2 years
  • Incidence of stroke at 1 and 2 years
  • Brain Natriuretic Peptide (BNP) levels at 1 and 2 years
  • NTproBNP levels at 1 and 2 years
  • Echocardiographic measures of cardiac dyssynchrony at 1 and 2 years
  • 6 minute walking distances at 1 and 2 years
 
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
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?

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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Left Ventricular Dysfunction
Other: RV lead placement site
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
238
April 2012
April 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Natalie Middleton Middleton natalie.middleton@medtronic.com
Australia,   New Zealand,   United Kingdom
 
 
NCT00461734
Medtronic UK Ltd, Medtronic UK Ltd
 
Medtronic Cardiac Rhythm Disease Management
 
Study Chair: Dr. Gerald Kaye Princess Alexandra Hospital
Medtronic Cardiac Rhythm Disease Management
April 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.