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Heart valve implants tested for leaky aortic valves

NCT ID NCT07021612

Knowledge-focused Sponsor: Prince of Wales Hospital, Shatin, Hong Kong 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are tracking outcomes for 30 people with severe pure aortic regurgitation who receive a transcatheter aortic valve implantation using the JenaValve or J-Valve system. All participants are considered high-risk for open heart surgery. The study uses CT scans at 6 months to check for leaflet thrombosis and MRI at 1 month to compare blood flow patterns before and after the procedure. The goal is to understand how these dedicated devices perform in this specific patient group.

What this could mean

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

Active substance
JenaValve and J-Valve transcatheter aortic valve implantation systems
What this could lead to
If the devices perform well, this could support TAVI as a treatment option for people with pure aortic regurgitation who are too high-risk for open heart surgery.
What could go wrong
This is a small observational registry with 30 participants, so it cannot prove the devices work or are safe. It may not capture rare complications or long-term durability.

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.

Participants

About 30 people

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

Started

Apr 2025

Expected to finish

Sep 2028

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.

Who is studied

Patients receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy

Ages

18 years and older

Sex

Anyone

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. receiving transcatheter aortic valve implantation (TAVI) (using Jenavalve/J-Valve) in PWH 2. with severe symptomatic AR (NYHA III-IV) despite optimal medical therapy 3. Deemed high risk for aortic valve surgery determined by a multidisciplinary heart team (including cardiologists, cardiac surgeons and cardiac anesthetists) 4. Capable of providing informed consent Exclusion Criteria: 1. Evidence of intracardiac mass, thrombus or vegetation 2. Anatomical structures precluding proper device deployment or device vascular access, evaluated by echo or CT 3. Sepsis or active endocarditis within 3 months, or infections requiring antibiotic therapy within 2 weeks prior to the planned procedure 4. Subjects currently participating in another clinical trial of an investigational drug or device that has not yet completed its primary endpoint. 5. Chronic Kidney Disease with eGFR \<30 ml/min/1.73m2. 6. Cardiogenic shock or other hemodynamic instability requiring inotropic support or ventricular assist device 7. Contraindicated for CT or MRI assessment

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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

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Shatin, 0000, Hong Kong

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