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 | Recruiting

• 1 other identifier: MARE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• -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

Secondary Outcomes (7)

• -Rate of high degree or complete of AVB

  Within the first month after TAVI procedure

• -Rate of high degree or complete of AVB

  6-month follow-up

• -Rate of high degree or complete AVB

  24-month follow-up

• -Rate of high degree or complete AVB

  36-month follow-up

• -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI

  Within the first 3 years following TAVI procedure

Study Arms (1)

Implantable loop recorders Reveal ICM LINQ®,

EXPERIMENTAL

Device: Implantable loop recorders system Reveal ICM LINQ®,

Interventions

Implantable loop recorders system Reveal ICM LINQ®, DEVICE

Implantable loop recorders Reveal ICM LINQ®,

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (26)

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  PMID: 33083813 DERIVED

• Rodes-Cabau J, Urena M, Nombela-Franco L, Amat-Santos I, Kleiman N, Munoz-Garcia A, Atienza F, Serra V, Deyell MW, Veiga-Fernandez G, Masson JB, Canadas-Godoy V, Himbert D, Castrodeza J, Elizaga J, Francisco Pascual J, Webb JG, de la Torre JM, Asmarats L, Pelletier-Beaumont E, Philippon F. Arrhythmic Burden as Determined by Ambulatory Continuous Cardiac Monitoring in Patients With New-Onset Persistent Left Bundle Branch Block Following Transcatheter Aortic Valve Replacement: The MARE Study. JACC Cardiovasc Interv. 2018 Aug 13;11(15):1495-1505. doi: 10.1016/j.jcin.2018.04.016. Epub 2018 Jul 18.

  PMID: 30031719 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Josep Rodes, MD

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 3, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2020
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CA (1)