Recruiting

Observational StudyAmbulatory 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

Sponsor:

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

Code:

NCT02153307

Conditions

Aortic Valve Disease

Conduction Disturbances

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Implantable loop recorders system Reveal ICM LINQ®,

Study Details

Brief 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.

Conditions

Aortic Valve Disease

Conduction Disturbances

Study ID

NCT02153307

Start date

Jan, 2014

Status verified date

Mar, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

May, 2020

Eligibility Criteria

Sex: All

Age: 18+

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

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Implantable loop recorders Reveal ICM LINQ®,

Interventions

Implantable loop recorders system Reveal ICM LINQ®,

Primary outcome measure

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

Central Contacts and Locations

Locations

IUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Emilie Pelletier Beaumont, M.Sc.

418-656-8711 Emilie.Pelletier-Beaumont@criucpq.ulaval.ca

More Information

Sponsor

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

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec on 2026-03-24.