Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study

Not Applicable

Active, not recruiting

• Conditions: TAVI; ECG Monitoring
• Interventions: Device: Cardiostat

• Registration Number: NCT04298593
• Lead Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Brief Summary

TAVI recipients exhibit a high burden of arrhythmic events early after the procedure. ECG continuous monitoring could be useful to diagnose and facilitate early implementation of specific therapeutic measures in these patients.

Detailed Description

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 after hospital discharge. Following the TAVI procedure, continuous ECG monitoring will start just before hospital discharge and prolonged up to 4 weeks. There won't be any 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 diagnosis of the arrhythmic event.

Analyses of the CardioSTAT will be done at 2 and 4 weeks following hospital discharge. Clinical follow-up will be performed at 14 days (analysis of CardioSTAT® record), 28 days (analysis of CardioSTAT record), 1 year post-TAVI and yearly thereafter up to 5-year follow-up.

Study Timeline

• Study Start: 2019-06-28
• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-06
• Primary Completion: 2021-12-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves.

Exclusion Criteria

• Failure to provide informed consent.
• Prior or post-procedural pacemaker
• In-hospital death
• Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure
• Participation in another continuous ECG monitoring post-TAVI trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECG monitoring	Cardiostat	All patient will be under telemetry

Primary Outcome Measures

Name	Time	Method
Incidence of arrhythmic events	within the first weeks after the procedure, an average of 4 weeks	Incidence of arrhythmic events after discharge in TAVI recipients.
Type of arrhythmic events	within the first weeks after the procedure, an average of 4 weeks	Type of arrhythmic events after discharge in TAVI recipients.
Type of arrhythmic events and treatment modification	within the first weeks after the procedure, an average of 4 weeks	Type of arrhythmic events leading to a specific change in treatment.
Incidence of arrhythmic events and treatment modification	within the first weeks after the procedure, an average of 4 weeks	Incidence of arrhythmic events leading to a specific change in treatment.

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment modification	Through study completion, an average of 5 years	Number of participants who required change in their medication (anticoagulation, antiarrhythmic) after the procedure.
Number of participants with pacemaker	Through study completion, an average of 5 years	Incidence of permanent pacemaker implantation after the procedure.

Trial Locations

Locations (1)

IUCPQ; 🇨🇦 Quebec, Canada