NCT03561805

Prolonged Continuous ECG Monitoring Prior to Transcatheter Aortic Valve Implantation

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Arrythmia

Interventions

Type	Name	Description
DEVICE	ECG monitoring	Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-01-31
• Completion: 2026-06-01
• First posted: 2018-06-19
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada