Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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Patients with severe aortic stenosis candidates for a TAVI procedure harbor a high burden of silent arrhythmic events. Pre-procedural detection of such arrhythmias should help the investigators to implement specific therapeutic measures that may improve patient outcomes and reduce hospitalization length post-TAVI.

Detailed Description
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This is a prospective registry including patients accepted by the heart team for a TAVI procedure. Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. All type of arrhythmic events will be recorded, as well as the specific therapeutic measures implemented upon the occurrence of the arrhythmic event. Following the TAVI procedure, the patients will be monitored (telemetry) until hospital discharge. All arrhythmic events during the hospitalization period will be recorded. Clinical follow-up will be performed at 30 days, and 1 year post-TAVI, and yearly thereafter up to 5-year follow-up.

Official Title
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Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study

Conditions
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Aortic Valve Stenosis, Arrythmia

Intervention / Treatment
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* Device: ECG monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe aortic stenosis accepted for a TAVI procedure by the Heart Team. Exclusion Criteria: Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure. Prior permanent pacemaker.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prolonged continuous ECG monitoring<br>Patients will undergo a prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure. The duration of the ECG monitoring will be of 1 week. | Device: ECG monitoring<br>* Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmic events | Incidence and type of arrhythmic events | Within 3 months prior to the TAVI procedure | 
| Therapeutic changes | incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure | Within 3 months prior to the TAVI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation | incidence of atrial fibrillation | Within 3 months prior to the TAVI procedure | 
| Atrial fibrillation | duration of atrial fibrillation | Within 3 months prior to the TAVI procedure | 
| Atrioventricular block | incidence of advanced atrioventricular block | Within 3 months prior to the TAVI procedure | 
| Severe bradycardia | incidence of severe bradycardia | Within 3 months prior to the TAVI procedure | 
| Left bundle branch block | incidence of left bundle branch block | Within 3 months prior to the TAVI procedure | 
| Permanent pacemaker | percentage of patients with an indication of permanent pacemaker | Within 3 months prior to the TAVI procedure | 
| Anticoagulation therapy | percentage of patients with an indication for anticoagulation therapy | Within 3 months prior to the TAVI procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAVI, ECG monitoring