Impact of pacemaker on cardiac function
The effect of permanent pacemaker implantation with lead in right ventricular apex (RVA) versus right ventricular outflow tract (RVOT) on cardiac function in patients requiring pacemakers due to heart block
University of Adelaide, Centre for Heart Rhythm Disorder
180 participants
May 1, 2013
Interventional
Conditions
Summary
Introduction: Right ventricular apical (RVA) pacing results in abnormal left ventricular (LV) electrical and mechanical activation and is associated with adverse effects on left ventricular systolic function. The comparative effects of right ventricular outflow tract septal (RVOTS) pacing on cardiac structural remodeling are unknown. Our aim is to therefore examine the long-term effects of septal RVOT versus RVA pacing on ventricular and atrial structure and function using cardiac magnetic resonance imaging (CMR). Methods/Design: A multicenter randomised controlled trial in which 180 patients with an indication for ventricular pacing using a permanent pacemakers (PPM) will be randomized to pacing either from the RVA or RVOT septum. All patients will have a baseline CMR, Echocardiogram, 6-minute walk test, quality of life scoring e.g. SF36, Minnesota Living with Heart Failure Score (MLWHF) and blood tests such as NT pro-BNP, HsCRP and biomarkers of myocardial fibrosis e.g. MMP-9, TIMP-1. The tests will be repeated at 12 months, 24 months and 36 months. The following clinical outcomes will be used: Primary Endpoint: Investigate the effect of apical and septal right ventricular site pacing on left ventricular structural change and ejection fraction using cardiac MRI. Secondary Endpoint: Clinical Parameters: New York Heart Association Functional class, Quality of life assessed by a subjective validated patient scoring algorithm (SF36/ MLWHF), 6 min walk test. Biologic Parameters: N-terminal pro-hormone brain natriuretic peptide (NT pro-BNP), High sensitivity C reactive Protein (HsCRP), Biomarkers of myocardial fibrosis e.g. MMP-9, TIMP-1. Combined clinical end point: New-onset atrial tachyarrhythmia, new onset heart failure, heart failure related hospitalizations. CRT-P, CRT-D or AICD upgrade. The Effect of cardiac remodeling on its hemodynamics. Lead-related complications such as lead dislodgement, myocardial perforation, lead Will integrity failure The impact of ventricular pacing site to right ventricular and atrial remodeling. Conclusion: The results of the study will provide new information about the potential benefits in mechanical function and consequent clinical endpoint(s) of septal versus apical pacing.
Eligibility
Inclusion Criteria3
- Age >18 years old
- Patients with high grade AV block
- Able and willing to comply with all pre-, post- and follow-up testing, and requirements
Exclusion Criteria14
- Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
- Myocardial Infarction, Bypass surgery or Valve replacement within 3 months prior to enrollment.
- 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.
- Known permanent atrial fibrillation 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.
- Pregnant patients.
- Musculo- skeletal disease hampering the realization of a 6-minute walk-test.
- Previous non MRI compatible device
- Renal Dysfunction with eGFR < 60ml/min
- Any contraindication for MRI
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Consecutive patients with AV block, scheduled to undergo dual chamber pacemaker implantation will be recruited into the study. Patients will be randomised to RVOT (Intervention arm) or RVA (Control arm) pacing groups according to a computer generated randomisation schedule. Patients who are randomised to intervention arm will have the pacemaker lead implanted in the right ventricular outflow tract (RVOT). These patients will be followed up 6 monthly for the period of study i.e 36 months and will have investigations as per schedule . The total duration of the procedure will be 60-90 minutes.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000461796