Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval
Academic / other
Locations1 site (Québec, Quebec)
StatusRecruiting
StartedJanuary 2014
Main results expectedMay 2020
Study endsJuly 2027
Registry record updatedNovember 4, 2026
Trial IDNCT02153307 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.

  • 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.

    Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec · NCT07739316

  • 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.

    Recruiting at 3 sites Edwards Lifesciences · München, Bavaria and 2 other locations · NCT07619872

  • Savvywire versus standard LV guidewires during transfemoral TAVI

    For people 50 and older having transfemoral TAVI, researchers will compare the Savvywire and standard LV guidewires to see if the Savvywire improves pacing and procedure-related blood flow.

    Recruiting Catharina Ziekenhuis Eindhoven · Eindhoven, North Brabant · NCT07366671

  • 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.

    Recruiting at 7 sites EmStop Inc · Thousand Oaks, California and 6 other locations · NCT07276711

  • Tracking progression and consequences of heart valve disease

    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.

    Recruiting at 15 sites Second Affiliated Hospital, Zhejiang University, School of Medicine · Fuzhou, Fujian and 14 other locations · NCT07267117

  • 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.

    Recruiting at 15 sites Edwards Lifesciences · Heidelberg, Baden-Wurttemberg and 14 other locations · NCT07120048

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.