Ambulatory ECG Monitoring for Aortic Stenosis
(RECORDII Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This multicenter, prospective, randomized superiority trial will evaluate whether systematic 14-day ambulatory ECG monitoring following hospital discharge after transcatheter aortic valve implantation (TAVI) reduces the risk of sudden death, symptomatic arrhythmic events, or stroke within 1 year compared with standard post-discharge care. Patients undergoing successful TAVI without permanent pacemaker implantation and presenting with at least one ECG conduction abnormality at hospital discharge will be randomized to receive either ambulatory ECG monitoring or standard follow-up. All participants will undergo routine clinical follow-up at 30 days and 1 year after TAVI.
Who Is on the Research Team?
Josep Rodes-Cabau, MSc
Principal Investigator
Fondation IUCPQ
Are You a Good Fit for This Trial?
This trial is for people who have had a successful TAVI procedure for aortic stenosis, do not have a permanent pacemaker, and show at least one abnormal heart rhythm on their ECG before leaving the hospital.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo transcatheter aortic valve implantation (TAVI) and are randomized to receive either ambulatory ECG monitoring or standard post-TAVI care
Follow-up
Participants are monitored for safety and effectiveness after treatment, with routine clinical follow-up at 30 days and 1 year after TAVI
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two groups: one uses a wearable heart monitor (ambulatory ECG) for 14 days after going home from TAVI, while the other gets standard care. The goal is to see if monitoring helps prevent sudden death or serious heart events within a year.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will undergo ambulatory ECG monitoring at hospital discharge following TAVI. Continuous ECG monitoring will be performed for 14 days using an ambulatory ECG monitoring device. Clinically significant bradyarrhythmias or tachyarrhythmias detected during monitoring will be reviewed and managed according to clinical practice, including appropriate therapeutic interventions when indicated.
Participants will receive standard post-TAVI care without systematic ambulatory ECG monitoring at hospital discharge. Clinical follow-up will be performed according to routine practice.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Lead Sponsor
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