Assessment of Arrhythmic BuRdEn With Post-ProCedural COntinuous ElectRocarDiographic Monitoring in Patients Undergoing Transcatheter Aortic Valve Implantation: The RECORD Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- TAVI
- Sponsor
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Incidence of arrhythmic events
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Josep Rodes-Cabau
MD, Principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
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
Outcomes
Primary Outcomes
Incidence of arrhythmic events
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: within the first weeks after the procedure, an average of 4 weeks
Incidence of arrhythmic events leading to a specific change in treatment.
Secondary Outcomes
- Number of participants with treatment modification(Through study completion, an average of 5 years)
- Number of participants with pacemaker(Through study completion, an average of 5 years)