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

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Status: Active, not recruiting

Conditions: ECG Monitoring; TAVI

Treatments: Device: Cardiostat

Study type: Interventional

Funder types: Other

Identifiers

NCT04298593

RECORD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

ECG monitoring

Other group

Description:

All patient will be under telemetry

Treatment:

Device: Cardiostat