N/A
N=240
PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing
Left Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00461734 ↗Enrolled (actual)
240
Serious AEs
66.3%
Results posted
Apr 2017
Primary outcome: Primary: Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). — -2.29; -3.43 percentage — p=0.4347
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RV lead placement site (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort). |
-2.29; -3.43 | 0.4347 |
| PRIMARY Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort). |
-2.04; -3.60 | 0.338 |
| SECONDARY Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) |
17.73; 63.83 | 0.8868 |
| SECONDARY Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) |
62.75; 18.61 | 0.6151 |
| SECONDARY Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort) |
17.73; 63.83 | 0.8868 |
| SECONDARY Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort) |
62.75; 18.61 | 0.6151 |
| SECONDARY Worsening of Heart Failure |
19; 17 | — |
| SECONDARY All Cause Mortality |
14; 11 | — |
| SECONDARY Incidence of Stroke |
5; 6 | — |
| SECONDARY Brain Natriuretic Peptide Levels (Intent to Treat Cohort) |
138.2; 111.3 | 0.0525 |
| SECONDARY Brain Natriuretic Peptide Levels (Per Protocol Cohort) |
176.6; 110.8 | 0.1852 |
| SECONDARY Echocardiographic Measures of Left Ventricular Dyssynchrony |
— | — |
| SECONDARY 6 Minute Hall-Walk Distance (Intent to Treat Cohort) |
391; 395 | 0.9719 |
| SECONDARY 6 Minute Hall-Walk Distance (Per Protocol Cohort) |
385.5; 426.5 | 0.8779 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00461734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.