Systematic Ambulatory ECG Monitoring Following TAVI | NCT07739316

NCT07739316

Overview

NCT ID: NCT07739316
Lead Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University LavalOTHER
Official Title: Systematic Ambulatory ECG Monitoring Following TAVI: A Prospective Randomized Trial.
Brief 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.
Conditions: Aortic Stenosis
Conduction Disturbances

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 31, 2026Actual
Start Date: Aug 2026Estimated
Primary Completion Date: Dec 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 754Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Josep Rodes-Cabau, MD, PhDContact
josep.rodes-cabau@criucpq.ulaval.ca

Similar Studies

Participant Group/Arms

Ambulatory ECG monitoringExperimental

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.

Device: Ambulatory ECG monitoring

Standard care (no ambulatory ECG monitoring device).No Intervention

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.