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New study tests best TAVI valve for small heart valves

NCT ID NCT03520101

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study compares two types of TAVI valves (Edwards and CoreValve Evolut) in 102 people with small, failing surgical aortic valves. The goal is to see which valve leads to fewer problems like high pressure or leakage after the procedure. Results could guide doctors in choosing the best valve for these patients.

What this could mean

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

Active substance
Transcatheter aortic valve implantation (TAVI) with either an Edwards or CoreValve Evolut device
What this could lead to
If successful, this could help doctors choose the best TAVI valve for patients with small surgical valves, potentially reducing the risk of high pressure or leakage after the procedure.
What could go wrong
This is a small pilot study with only 102 participants, so results may not apply to everyone. The procedure itself carries risks like bleeding, stroke, or valve problems.

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

102 people

The number who actually took part.

Started

May 2017

Expected to finish

May 2030

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 surgical aortic bioprosthetic dysfunction defined as severe aortic stenosis and/or regurgitation approved for a ViV procedure by the Heart Team * Stented surgical valves. * Small (≤23mm) surgical valve Exclusion Criteria: \- Stentless or sutureless surgical valves

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis Prosthesis Failure

As listed by the trial registrant

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

Aortic valve stenosis Prosthesis failure Regurgitation, aortic

Contacts and locations

Locations

  • IUCPQ

    Québec, Quebec, G1V 4G5, Canada

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