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NCT07739316
Systematic Ambulatory ECG Monitoring Following TAVI
Conditions: Aortic Stenosis, Conduction Disturbances
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 754
Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Location: Institut universitaire de cardiologie et de pneumologie de Québec - UL Québec Quebec
Summary
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
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07739316). StuddyBuddy aggregates publicly available trial information.
