Prolonged Continuous ECG Monitoring Prior to TrAnscatheter AoRtic ValvE Implantation: the PARE Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- Enrollment
- 106
- Locations
- 1
- Primary Endpoint
- Arrhythmic events
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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
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.
Investigators
Josep Rodes-Cabau
Principal investigator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Arrhythmic events
Time Frame: Within 3 months prior to the TAVI procedure
Incidence and type of arrhythmic events
Therapeutic changes
Time Frame: Within 3 months prior to the TAVI procedure
incidence of arrhythmic events identified by the device leading to therapeutic changes prior to the TAVI procedure
Secondary Outcomes
- Atrial fibrillation(Within 3 months prior to the TAVI procedure)
- Atrioventricular block(Within 3 months prior to the TAVI procedure)
- Severe bradycardia(Within 3 months prior to the TAVI procedure)
- Left bundle branch block(Within 3 months prior to the TAVI procedure)
- Permanent pacemaker(Within 3 months prior to the TAVI procedure)
- Anticoagulation therapy(Within 3 months prior to the TAVI procedure)