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Heart valve fix may heal scarred muscle, small study hints

NCT ID NCT07335900

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at whether replacing a narrowed heart valve (TAVI) can reverse damage to the heart muscle in people with severe aortic stenosis. Researchers will use special PET scans to measure scarring and remodeling in the heart before and 6 months after the procedure. The goal is to understand if relieving the blockage helps the heart heal and work better.

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) procedure
What this could lead to
If successful, this could show that TAVI not only fixes the valve but also helps reverse heart muscle scarring and improve heart function.
What could go wrong
This is a small, early-stage imaging study (25 people) with no control group for the procedure. It measures changes in scans, not long-term health outcomes, so results may not lead to direct treatment changes.

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 25 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

May 2027

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: ① Age 18 years or older, any gender; ② Confirmed diagnosis of severe degenerative aortic stenosis by echocardiography (valve area AVA \< 1.0 cm² or mean transvalvular gradient \> 40 mmHg; for AS with reduced ejection fraction and low-flow, low-gradient, the presence of outflow tract reserve must be confirmed with dobutamine stress); ③ Evaluated by the heart team as unsuitable for surgical open-heart valve replacement due to advanced age or severe comorbidities, without anatomical contraindications, and expected to benefit from transcatheter valve implantation. Patients who meet these criteria and decide to undergo TAVI will be assigned to the TAVI group; those who meet the criteria but do not undergo valve replacement will enter the control group (possible scenarios include: relatively mild valve stenosis not meeting TAVI indication, or patient refusal of surgery, opting for drug therapy only, etc.). Exclusion Criteria: * Recent acute myocardial infarction (less than 1 month from onset to enrollment) or the presence of active myocarditis, infectious endocarditis, and other acute inflammatory conditions, as these conditions can significantly affect FAPI uptake and cardiac function; ② History of old myocardial infarction (with existing myocardial scarring and remodeling, which affect fibroblast imaging); ③ Presence of uncontrolled severe arrhythmias, such as persistent ventricular tachycardia, ventricular fibrillation, or high-risk second-degree or higher atrioventricular block, resulting in hemodynamic instability due to arrhythmia within the past 3 months; ④ Concomitant severe cardiovascular diseases affecting study evaluation, including severe valvular disease (excluding AS, such as severe mitral regurgitation), hypertrophic obstructive cardiomyopathy, primary pulmonary hypertension, etc.; ⑤ Presence of examination contraindications: allergy to PET tracers or MRI contrast agents, severe renal insufficiency (eGFR \<30 ml/min/1.73 m²) with inability to tolerate gadolinium-enhanced MRI, or severe claustrophobia preventing compliance with imaging examinations; ⑥ Allergic constitution (history of allergy to multiple drugs or unknown substances); ⑦ Pregnant or breastfeeding women (female subjects of childbearing potential must provide a negative pregnancy test before enrollment and use effective contraception during the study); ⑧ Any other situation that the investigator believes could significantly increase study risk or interfere with result interpretation, such as active malignant tumors or advanced disease with expected survival of less than 1 year; ⑨ Inability to comply with the trial protocol or follow-up requirements (e.g., poor prior adherence, expected inability to attend scheduled follow-ups).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Renji Hospital,Shanghai

    RECRUITING

    Shanghai, 201203, China

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