Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Tr

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 Summary: 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.
Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Current Primary Outcome:

  • -Rate and time of onset of high degree or complete AVB [ Time Frame: 1Year ]
  • -Incidence of arrhythmic events identified by the IRL leading to a change in treatment or major adverse event [ Time Frame: 1 Year ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • -Rate of high degree or complete of AVB [ Time Frame: Within the first month after TAVI procedure ]
  • -Rate of high degree or complete of AVB [ Time Frame: 6-month follow-up ]
  • -Rate of high degree or complete AVB [ Time Frame: 24-month follow-up ]
  • -Rate of high degree or complete AVB [ Time Frame: 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 [ 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.
  • -Rate of new atrial fibrillation or ventricular arrhythmias [ Time Frame: Within the first 3 years following TAVI procedure ]
  • -Changes in left ventricular function and mitral regurgitation over time [ Time Frame: Within the first 3 years following TAVI procedure ]


Original Secondary Outcome: Same as current

Information By: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Dates:
Date Received: May 26, 2014
Date Started: January 2014
Date Completion: July 2018
Last Updated: May 9, 2017
Last Verified: May 2017