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

NCT02153307 · tracked via the Priya Life Science Canada tracker

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Phase

Not applicable

Started

2014-01

Last updated

2026-03-24

Condition(s) studied

Aortic Valve DiseaseConduction Disturbances

Investigational drug(s) / intervention(s)

Implantable loop recorders system Reveal ICM LINQ®,

Study summary

The purpose of this study is to determine the incidence and predictors of high degree or complete atrioventricular block (AVB) (paroxysmal or persistent) in patients with new-onset persistent left bundle branch block (NOP-LBBB) following transcatheter aortic valve implantation (TAVI) and to evaluate the usefulness of the Reveal LINQ® insertable Cardiac Monitor (ICM) (Medtronic, Inc., Minneapolis, USA) for the detection of significant arrhythmias in patients with NOP-LBBB following TAVI.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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

Primary outcome measure(s)

-Rate and time of onset of high degree or complete AVB — 1Year
-Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event — 1 Year

Trial sites (1)

Facility	City	Region	Status
IUCPQ	Québec	Quebec	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02153307 on ClinicalTrials.gov ↗ ← All trials in Canada