CompletedNot Applicable

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

Australia248 participantsStarted 2007-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 proble…

What they're measuring

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

Timeframe: At 2-year follow-up

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

Timeframe: At 2-year follow-up

Trial details

NCT IDNCT00461734

SponsorMedtronic Cardiac Rhythm and Heart Failure

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-10

Results submitted2016-09-15