Monitoring heart rhythms in patients with new left bundle branch block after heart valve surgery
Official title: 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
Run by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · NCT02153307 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | January 2014 |
| Main results expected | May 2020 |
| Study ends | July 2027 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT02153307 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients undergoing transcatheter aortic valve implantation who develop new-onset persistent left bundle branch block.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in using implantable cardiac monitors for detecting arrhythmias, suggesting this approach may be beneficial.
Who can join: the full rules
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 it's running
-
Iucpq
Québec, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Josep Rodes, MD — Fondation IUCPQ
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Systematic 14-day ambulatory heart monitoring after TAVI
After TAVI, patients with certain heart conduction abnormalities will try 14 days of wearable ECG monitoring to see if it lowers the chances of sudden death, symptomatic heart rhythm problems, or stroke within a year compared to standard follow-up.
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KONECT RESILIA Aortic Valved Conduit real-world use in adults needing valve and ascending aorta replacement
This study tests how the KONECT RESILIA aortic valved conduit performs in adults needing aortic valve and ascending aorta replacement.
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EmStop Embolic Protection System for TAVR in Aortic Valve Stenosis
This study tests whether the EmStop protective device can safely capture and remove debris during transcatheter aortic valve replacement in adults with severe aortic valve stenosis.
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This project will follow adults with moderate or worse valve disease to see if clinical tests and imaging can predict when their condition will get worse.
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Real-world outcomes of the INSPIRIS RESILIA aortic valve in adults
This registry will collect real-world data to see how the INSPIRIS RESILIA aortic valve performs in adults undergoing aortic valve replacement.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.