RecruitingNot ApplicableNCT02153307

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


Sponsor

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

Enrollment

80 participants

Start Date

Jan 1, 2014

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria4

  • 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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Interventions

DEVICEImplantable loop recorders system Reveal ICM LINQ®,

Locations(1)

IUCPQ

Québec, Quebec, Canada

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NCT02153307


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