Monitoring heart rhythms in patients with new left bundle branch block after heart valve surgery
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
This study is testing how often heart rhythm problems happen in patients who develop a new heart condition after valve surgery and will use a special device to monitor their heartbeats during recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT02153307 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the occurrence and predictors of high-degree atrioventricular block in patients who develop new-onset persistent left bundle branch block following transcatheter aortic valve implantation. Patients will be monitored with an implantable loop recorder to detect significant arrhythmias during their recovery. The study involves daily ECG monitoring during hospitalization and follow-up visits at 1, 12, 24, and 36 months post-procedure. The goal is to improve understanding of arrhythmia risks in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing transcatheter aortic valve implantation who develop new-onset persistent left bundle branch block.
Not a fit: Patients with pre-existing complete left bundle branch block or those with a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management and monitoring of patients at risk for serious heart rhythm disturbances after valve surgery.
How similar studies have performed: Other studies have shown promise in using implantable cardiac monitors for detecting arrhythmias, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -Patients undergoing TAVI with either balloon or self-expandable valves who develop new-onset LBBB persistent at hospital discharge, at least 3 days after the procedure Exclusion Criteria: * Failure to provide informed consent * Baseline pacemaker/defibrillator or pacemaker/defibrillator implanted during the hospitalization period following the TAVI procedure * Pre-existing complete LBBB * Patients with a life-expectancy of less than 2 years
Where this trial is running
Québec, Quebec
- Iucpq — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Josep Rodes, MD — Fondation IUCPQ
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.