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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2025
  • participants needed
    200
  • sponsor
    Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Updated on 24 January 2021

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.

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.

Details
Condition TAVI, ECG Monitoring, transcatheter aortic valve implant, electrocardiographic monitoring
Treatment Cardiostat
Clinical Study IdentifierNCT04298593
SponsorCentre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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