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Blood test may replace anesthesia for heart valve fix

NCT ID NCT03728049

Diagnosis Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a quick blood test (CT-ADP) can help doctors detect and fix leaks around a new heart valve during a minimally invasive TAVI procedure. Currently, doctors often use general anesthesia and an ultrasound probe in the throat to check for leaks, but this study avoids that. About 944 people with aortic stenosis will be randomly assigned to have the blood test or not, and researchers will track complications over one year.

What this could mean

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

Active substance
CT-ADP blood test
What this could lead to
If successful, this blood test could replace the need for general anesthesia during TAVI while still catching dangerous leaks, making the procedure safer and less invasive.
What could go wrong
This is a large but early-stage trial testing a new use for an existing test. The test may not be accurate enough to replace current methods, and the study's success depends on many factors.

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 944 people

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

Started

Dec 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: * All patients scheduled to undergo mini-invasive TAVI at any of the participating centers and fulfilling the inclusion criteria will be eligible for entry in the study. The decision to undertake TAVI will be made by the local heart team. * Symptomatic aortic stenosis scheduled to undergo TAVI * TAVI performed via mini-invasive approach defined as: transfemoral access route; local anesthesia/conscious sedation; no TEE guidance. * All types of prosthetic valves (balloon-expandable, self-expandable, others) are accepted Exclusion Criteria: * TAVI through non-transfemoral approach * TAVI with concomitant percutaneous coronary intervention * TAVI performed under general anesthesia * TAVI performed under TEE guidance * Valve-in-valve procedure * Inability to provide informed consent * Associated ≥ moderate mitral regurgitation * Peri-procedural treatment with ticagrelor or prasugrel treatment / direct oral anticoagulant

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Conditions

The condition(s) this trial relates to.

aortic valve insufficiency aortic valve stenosis

As listed by the trial registrant

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

Aortic valve insufficiency Aortic valve stenosis

How to take part

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

  1. The places running it

    9 sites. 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

  • CHU de Nimes

    NOT_YET_RECRUITING

    Nîmes, France

  • CHU de Toulouse

    RECRUITING

    Toulouse, France

  • Chru Rennes Site Pontchaillou

    NOT_YET_RECRUITING

    Rennes, France

  • Chu Montpellier

    NOT_YET_RECRUITING

    Montpellier, France

  • Hopital Civil / Nouvel Hopital Civil - Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, France

  • Hopital Estaing - Chu63 - Clermont Ferrand

    RECRUITING

    Clermont-Ferrand, France

  • Hopital Haut-Leveque - Chu - Pessac

    RECRUITING

    Pessac, 33604, France

  • Hu Pitie Salpetriere Aphp - Paris 13

    NOT_YET_RECRUITING

    Paris, France

  • Institut Coeur-Poumon, CHU

    RECRUITING

    Lille, 59037, France

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