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New heart valve procedure could help patients with leaky aortic valve

NCT ID NCT06818084

Disease control Sponsor: Ruijin Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a new way to replace the aortic valve in people with severe aortic regurgitation (a leaky heart valve). About 180 patients will get either the new VitaFlow valve or another device through a tube in the leg. The goal is to see if the new valve is safe and effective at reducing death, stroke, and hospital readmissions over one year.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 120 people

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

Started

Apr 2025

Expected to finish

Nov 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

60 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 Age ≥ 60 years. Symptomatic moderate-to-severe or greater isolated aortic regurgitation. Asymptomatic moderate-to-severe or greater isolated aortic regurgitation meeting at least one of the following criteria: LVEF ≤ 55% (measured by biplane Simpson's method); LVESD \> 50 mm ; LVESDi \> 22 mm/mm²； LVESVi \> 45mL/m2 Anatomical suitability for TAVR as assessed by the heart team. Provision of written informed consent by the patient or their legal guardian, with agreement to the treatment plan and willingness and ability to comply with all required follow-up assessments. Exclusion Criteria Incomplete coronary revascularization. Less than 30 days of guideline-directed medical therapy at maximally tolerated doses. Life expectancy \< 1 year. LVEF \< 45%. eGFR \< 30 mL/min/1.73m². Known allergy or contraindication to required medications (e.g., aspirin, clopidogrel, warfarin) or contrast media. Any condition that precludes contrast-enhanced CT. Concurrent moderate-to-severe or severe valvular heart disease other than aortic regurgitation. Poor patient compliance, unable to complete follow-up as required. Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

Aortic Valve Disease aortic valve disorder aortic valve insufficiency

As listed by the trial registrant

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

Aortic regurgitation Aortic valve diseases Transcatheter aortic valve replacement (TAVR)

How to take part

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

  1. The places running it

    4 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

  • Changhai Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

  • Ruijin hospital, Shanghai JiaoTong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200030, China

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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