Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Valve Disease
Conduction Disturbances
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2014-06-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

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

Primary outcomes:
measure: -Rate and time of onset of high degree or complete AVB
timeFrame: 1Year
measure: -Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event
timeFrame: 1 Year
Secondary outcomes:
measure: -Rate of high degree or complete of AVB
timeFrame: Within the first month after TAVI procedure
measure: -Rate of high degree or complete of AVB
timeFrame: 6-month follow-up
measure: -Rate of high degree or complete AVB
timeFrame: 24-month follow-up
measure: -Rate of high degree or complete AVB
timeFrame: 36-month follow-up
measure: -Electrocardiographic and device-related factors predicting the occurence of high degree or complete AVB in patients with new-onset LBBB after TAVI
timeFrame: Within the first 3 years following TAVI procedure
measure: -Rate of new atrial fibrillation or ventricular arrhythmias
timeFrame: Within the first 3 years following TAVI procedure
measure: -Changes in left ventricular function and mitral regurgitation over time
timeFrame: Within the first 3 years following TAVI procedure
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
affiliation: Fondation IUCPQ
name: Josep Rodes, MD
role: PRINCIPAL_INVESTIGATOR
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