Recruiting

ECG Monitoring

Sponsor:

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Code:

NCT07739316

Conditions

Aortic Stenosis

Conduction Disturbances

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ambulatory ECG monitoring

Study Details

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

Study ID

NCT07739316

Start date

Oct 23, 2026

Status verified date

Nov, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

754 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ambulatory ECG monitoring

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.

no intervention: Standard care (no ambulatory ECG monitoring device).

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.

Interventions

Ambulatory ECG monitoring

Participants randomized to the intervention arm will undergo systematic ambulatory ECG monitoring at hospital discharge following the TAVI procedure. A wearable ambulatory ECG monitoring device will be applied for continuous rhythm monitoring during a 14-day period. The device will allow detection of clinically significant bradyarrhythmias and tachyarrhythmias. Detected arrhythmic events will be reviewed by the study team, and appropriate clinical management, including further evaluation or therapeutic intervention, will be performed according to the nature of the detected abnormality and standard clinical practice.

Primary outcome measure

  • Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke) [ Time Frame: Within the year following the TAVI procedure ]

Central Contacts and Locations

Central contacts

Josep Rodes-Cabau, MD, PhD

14186568711josep.rodes-cabau@criucpq.ulaval.ca

Emilie Pelletier Beaumont, MSc

4186568711emilie.pelletier-beaumont@criucpq.ulaval

Locations

Institut universitaire de cardiologie et de pneumologie de Québec - UL

Recruiting

Québec, Quebec, Canada, G1Y 4G5

Contacts

Emilie Pelletier beaumont, MSc

4186568711emilie.pelletier-beaumont@criucpq.ulaval.ca

Principal Investigator:

Josep Rodes-Cabau, MD, PhD

More Information

Sponsor

Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • TAVI
  • Ambulatory Electrocardiographic Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Institut universitaire de cardiologie et de pneumologie de Québec, University Laval on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.