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Can a wearable monitor prevent heart emergencies after valve replacement?

NCT ID NCT07739316

Disease control Sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether wearing a portable heart monitor for two weeks after a TAVI procedure can reduce the risk of sudden death, dangerous heart rhythms, or stroke within the following year. People who have had a successful TAVI and show certain electrical abnormalities on their ECG at discharge may participate. Half will receive the monitor, while the other half will receive standard care, and outcomes will be compared.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ambulatory ECG monitoring device
What this could lead to
If effective, this approach could become standard care after TAVI, potentially reducing life-threatening heart rhythm complications.
What could go wrong
The trial is early and may not show a clear benefit. Extra monitoring could lead to unnecessary procedures or anxiety.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 754 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis cardiac conduction defect

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis Conduction disturbances

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institut universitaire de cardiologie et de pneumologie de Québec - UL

    Québec, Quebec, G1Y 4G5, Canada

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