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New study uses wearable ECG to catch hidden heart problems after TAVI

NCT ID NCT04298593

Knowledge-focused 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 200 people who had a heart valve replacement (TAVI) to see how often they experience heart rhythm problems in the weeks after the procedure. Participants wear a portable ECG monitor for up to 4 weeks after leaving the hospital. The goal is to learn how common these rhythm issues are and whether early detection leads to changes in treatment.

What this could mean

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

Active substance
CardioSTAT continuous ECG monitoring device
What this could lead to
If successful, this could show that home ECG monitoring after TAVI helps catch heart rhythm issues early, leading to quicker treatment adjustments.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes. It may not prove that monitoring changes long-term health.

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 200 people

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

Started

Jun 2019

Expected to finish

Dec 2026

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: * Patients with severe aortic stenosis undergoing TAVI with either balloon or self-expandable valves. Exclusion Criteria: * Failure to provide informed consent. * Prior or post-procedural pacemaker * In-hospital death * Logistic reasons precluding ECG monitoring within the 4 weeks after the procedure * Participation in another continuous ECG monitoring post-TAVI trial

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

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

Ecg monitoring TAVI

Contacts and locations

Locations

  • IUCPQ

    Québec, Quebec, G1V 4G5, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.