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Recruiting NCT02153307

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

Trial Parameters

Condition Aortic Valve Disease
Sponsor Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2014-01
Completion 2020-05
Interventions
Implantable loop recorders system Reveal ICM LINQ®,

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.

Eligibility 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

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