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New heart valve implant could offer hope for leaky aortic valve patients

NCT ID NCT04864145

Disease control Sponsor: Nanjing First Hospital, Nanjing Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a new, less invasive heart valve implant (TAVR) with standard medication for people who have severe aortic regurgitation, a condition where the heart's aortic valve doesn't close properly. The trial will enroll 210 participants across multiple centers. The goal is to see if the implant reduces the risk of death, disabling stroke, or heart failure hospitalization compared to medication alone.

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 (TAVR) device (VitaFlow system)
What this could lead to
If successful, this could provide a less invasive treatment option for people with severe aortic regurgitation who are not candidates for open-heart surgery.
What could go wrong
This is a relatively early study with 210 participants, so results may not apply to everyone. The procedure carries risks like bleeding, need for a permanent pacemaker, or other complications.

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 210 people

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

Started

May 2021

Expected to finish

May 2031

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 to 90 years

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. Procedural indications: symptomatic severe aortic regurgitation; no symptom plus left ventricular ejection fraction ≤ 55% or left ventricular end-diastolic dimension (LVEDD) \> 65mm or left ventricular end-systolic dimension (LVESD) \> 50mm; 2. Severe aortic valve regurgitation, and mean pressure gradient \< 20mmHg; Annular perimeter ≤ 85 mm; 3. The ratio of the perimeter of the left ventricular outflow tract 4mm to the perimeter of the valve annulus is 0.95-1.05; 4. STS score ≥8 or moderate to severe frailty or refused surgical valve replacement or presence of any of the following factors judged to be difficult to perform the surgical valve replacement: 1. Severe aorta calcification or active ascending aorta atherosclerotic plaque 2. History of mediastinum radiotherapy 3. Past mediastinitis 4. Presence of unobstructed coronary bypass implants 5. Previous more than two cardiothoracic surgeries 6. Liver cirrhosis 7. Other surgical risk factors Exclusion Criteria: 1. Age \< 60 years old; 2. Ascending aorta diameter \>45mm; 3. Coronary multi-vessel disease (SYNTAX score \>32); 4. Life expectancy \<1 year; 5. Left ventricular ejection fraction \<30%; 6. Acute myocardial infarction within 30 days; 7. Allergies or contraindications to related drugs (aspirin, clopidogrel, warfarin, or contrast agents); 8. Other situations judged by the researcher as unsuitable for participating in 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 valve disease

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

  • Nanjing First Hospital

    RECRUITING

    Nanjing, Jiangsu, 210006, China

More trials for these conditions

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