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Systematic Ambulatory ECG Monitoring Following TAVI

NCT07739316 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2026-07-31

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Josep Rodes-Cabau, MSc · Fondation IUCPQ

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07739316 on ClinicalTrials.gov