Clinical trial NCT04298593: Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
Official title: Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: TAVI
ECG Monitoring
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective registry
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of arrhythmic events
timeFrame: within the first weeks after the procedure, an average of 4 weeks
measure: Type of arrhythmic events
timeFrame: within the first weeks after the procedure, an average of 4 weeks
measure: Incidence of arrhythmic events and treatment modification
timeFrame: within the first weeks after the procedure, an average of 4 weeks
measure: Type of arrhythmic events and treatment modification
timeFrame: within the first weeks after the procedure, an average of 4 weeks
Secondary outcomes:
measure: Number of participants with pacemaker
timeFrame: Through study completion, an average of 5 years
measure: Number of participants with treatment modification
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References:
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