Status:
COMPLETED
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Left Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 resultin...
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 functi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT00461734
Start Date
August 1 2007
End Date
September 1 2015
Last Update
April 25 2017
Active Locations (18)
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1
Princess Alexandra Hospital
Brisbane, Queensland, Australia
2
Royal Brisbane & Womens' Hospital
Brisbane, Queensland, Australia
3
The Prince Charles Hospital
Brisbane, Queensland, Australia
4
Calvary Wakefield Hospital
Adelaide, South Australia, Australia