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Hidden heart rhythms: new study monitors patients before valve surgery

NCT ID NCT03561805

Knowledge-focused Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether wearing a portable heart monitor for up to three months before a TAVI procedure can detect silent arrhythmias in people with severe aortic stenosis. The goal is to see if catching these hidden rhythm issues early can lead to treatments that improve outcomes and shorten hospital stays. About 106 participants will wear the CardioSTAT® device, and researchers will track any arrhythmias found and resulting changes in care.

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 extended monitoring before TAVI helps doctors find and treat hidden heart rhythm problems, possibly leading to better outcomes and shorter hospital stays.
What could go wrong
This is a small, early-stage observational study (106 participants) with no control group, so results may not apply broadly. The monitoring device may also miss some arrhythmias or cause false alarms.

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

106 people

The number who actually took part.

Started

Jun 2017

Expected to finish

Jun 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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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 accepted for a TAVI procedure by the Heart Team. Exclusion Criteria: * Urgent TAVI procedure or logistic reasons precluding an ECG monitoring of at least 1 week within the 3 months prior to the TAVI procedure. * Prior permanent pacemaker.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac cardiac rhythm disease

As listed by the trial registrant

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

Aortic valve stenosis Arrythmia

Contacts and locations

Locations

  • IUCPQ

    Québec, Quebec, G1V 4G5, Canada

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