Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Status: Active, not recruiting

Conditions: Arrythmia; Aortic Valve Stenosis

Treatments: Device: ECG monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03561805

PARE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

Prolonged continuous ECG monitoring

Other group

Description:

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.

Treatment:

Device: ECG monitoring