Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Arrythmia
• Interventions: Device: ECG monitoring

• Registration Number: NCT03561805
• Lead Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-04-13
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-19
• Primary Completion: 2020-01-31
• Status Verified: 2024-06
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prolonged continuous ECG monitoring	ECG monitoring	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.

Primary Outcome Measures

Name	Time	Method
Arrhythmic events	Within 3 months prior to the TAVI procedure	Incidence and type of arrhythmic events
Therapeutic changes	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 Outcome Measures

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

Trial Locations

Locations (1)

IUCPQ; 🇨🇦 Québec, Quebec, Canada