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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aortic Valve Disease, Conduction Disturbances

Intervention / Treatment
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* Device: Implantable loop recorders system Reveal ICM LINQ®,


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantable loop recorders Reveal ICM LINQ®,<br> | Device: Implantable loop recorders system Reveal ICM LINQ®,<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -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 | 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. | Within the first 3 years following TAVI procedure | 
| -Rate of new atrial fibrillation or ventricular arrhythmias |  | Within the first 3 years following TAVI procedure | 
| -Changes in left ventricular function and mitral regurgitation over time |  | Within the first 3 years following TAVI procedure |