Systematic Ambulatory ECG Monitoring Following TAVI

NCT07739316 | Not Yet Recruiting

• 1 other identifier: RECORDII- MP-10-2026-4441
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 1

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

Keywords

TAVI; Ambulatory Electrocardiographic Monitoring

Outcome Measures

Primary Outcomes (1)

• Rate of the combined endpoint (sudden death, symptomatic arrhythmias or stroke)

  Composite endpoint including sudden death, symptomatic arrhythmias, or stroke.

  Within the year following the TAVI procedure

Secondary Outcomes (25)

• Incidence of sudden death

  1 year after TAVI

• Incidence of symptomatic arrhythmias

  1 year after TAVI

• Incidence of stroke

  1 year after TAVI

• Incidence of PPI

  30 days after TAVI

• Incidence of PPI

  1 year after TAVI

Study Arms (2)

Ambulatory ECG monitoring

EXPERIMENTAL

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.

Interventions

Ambulatory ECG monitoring DEVICE

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.

Ambulatory ECG monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec - UL

Québec, Quebec, G1Y 4G5, Canada

Location

Related Publications (28)

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MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Josep Rodes-Cabau, MSc

  Fondation IUCPQ

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Rodes-Cabau, MD, PhD

CONTACT

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

Emilie Pelletier Beaumont, MSc

CONTACT

4186568711; emilie.pelletier-beaumont@criucpq.ulaval

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial comparing AECG monitoring for 14 days, vs. no AECG monitoring in patients undergoing succesfull TAVI.

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07

Locations

CA (1)