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Systematic Ambulatory ECG Monitoring Following TAVI

ConditionsAortic StenosisConduction Disturbances
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut universitaire de cardiologie et de pneumologie de Québec, University Laval

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

754 Participants
are divided into 2 treatment groups
Group A: Ambulatory ECG monitoringExperimental treatment 1 intervention
Group B: Standard care (no ambulatory ECG monitoring device).No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
Within the year following the TAVI procedure

Secondary outcomes

1

Incidence of sudden death

Sudden death

Time frame
1 year after TAVI
2

Incidence of symptomatic arrhythmias

All symptomatic arrhythmias events

Time frame
1 year after TAVI
3

Incidence of stroke

All stroke events

Time frame
1 year after TAVI
4

Incidence of PPI

Number of patients with PPI

Time frame
30 days after TAVI

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: