Systematic Ambulatory ECG Monitoring Following TAVI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval
About 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.
Eligibility criteria
Qualifiers
Age >18 years
Successful TAVI procedure.
Hospitalization discharge ≤72 hrs following the TAVI procedure.
Presence of at least 1 ECG abnormality at hospital discharge (QRS ≥120 ms OR PR ≥200 ms)
Disqualifiers
Pacemaker implantation (pre- TAVI or during hospitalization after the procedure).
TAVI valve-in-valve procedure
Any complication or logistic reason precluding hospital discharge ≤72 hrs following the TAVI procedure.
Impossibility to obtain signed informed consent.
Trial design
Treatments tested in this trial
- Ambulatory ECG monitoring
Treatment groups
754 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov