Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03561805
• Other study ID #: PARE
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: June 1, 2026
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Arrythmia

Intervention

Device:
• ECG monitoring
Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure

Locations

Country	Name	City	State
Canada	IUCPQ	Québec	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmic events	Incidence and type of arrhythmic events	Within 3 months prior to the TAVI procedure
Primary	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	Atrial fibrillation	incidence of atrial fibrillation	Within 3 months prior to the TAVI procedure
Secondary	Atrial fibrillation	duration of atrial fibrillation	Within 3 months prior to the TAVI procedure
Secondary	Atrioventricular block	incidence of advanced atrioventricular block	Within 3 months prior to the TAVI procedure
Secondary	Severe bradycardia	incidence of severe bradycardia	Within 3 months prior to the TAVI procedure
Secondary	Left bundle branch block	incidence of left bundle branch block	Within 3 months prior to the TAVI procedure
Secondary	Permanent pacemaker	percentage of patients with an indication of permanent pacemaker	Within 3 months prior to the TAVI procedure
Secondary	Anticoagulation therapy	percentage of patients with an indication for anticoagulation therapy	Within 3 months prior to the TAVI procedure