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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

Emilie Pelletier Beaumont, M.Sc.

CONTACT

[email protected]

418-656-8711 ext. 3929

About this study

This is a prospective observational study including patients undergoing TAVI with either self- or balloon-expandable valves. After the procedure, patients will be on ECG monitoring during the hospitalization period (or at least 72 hours), and an ECG will be performed daily until hospital discharge in all patients. Patients with new-onset persistent LBBB at hospital discharge (new-onset LBBB of a duration of at least 48 h which persists at hospital discharge, at least 3 days and up to 15 days after the procedure) will receive an implantable loop recorder Reveal ICM LINQ®, which will be implanted subcutaneously to record adequate QRS complexes and P waves. The patients will be followed in outpatient clinic visits at 1, 12, 24 and 36 months after TAVR, or if symptoms suggestive of cardiac origin or relevant arrhythmic events occur. The device will be manually interrogated in each visit. Phone contacts will be also carried out every three months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable loop recorders system Reveal ICM LINQ®,

Device

Primary outcomes

  1. -Rate and time of onset of high degree or complete AVB

    Time frame: 1Year

  2. -Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event

    Time frame: 1 Year

Secondary outcomes

  1. -Rate of high degree or complete of AVB

    Time frame: Within the first month after TAVI procedure

  2. -Rate of high degree or complete of AVB

    Time frame: 6-month follow-up

  3. -Rate of high degree or complete AVB

    Time frame: 24-month follow-up

  4. -Rate of high degree or complete AVB

    Time frame: 36-month follow-up

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

    Time frame: Within the first 3 years following TAVI procedure

    Periprocedural results of TAVI of patients with NOP-LVV will be used to characterize predictors of high degree or complete AVB. Moreover, electrocardiographic characteristics at hospital discharge of patients with NOP-LVV will also be used to characterize predictors of high degree or complete AVB.

  6. -Rate of new atrial fibrillation or ventricular arrhythmias

    Time frame: Within the first 3 years following TAVI procedure

  7. -Changes in left ventricular function and mitral regurgitation over time

    Time frame: Within the first 3 years following TAVI procedure

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: MARE

Important dates

Study start
2014
Primary completion
2020
Study completion
2026
First posted
Jun 3, 2014
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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