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New heart valve fix without Open-Heart surgery shows promise

NCT ID NCT07174531

Disease control Sponsor: Beijing Balance Medical Technology Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new device called the Renato® system, which allows doctors to place a new heart valve inside a failing one using a thin tube (catheter), avoiding repeat open-heart surgery. It enrolled 150 patients with deteriorated bioprosthetic valves who were at high risk for surgery. The goal was to see if the procedure is safe and effective at restoring valve function.

What this could mean

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

Active substance
Renato® transcatheter valve-in-valve system (a new artificial heart valve delivered through a tube)
What this could lead to
If successful, this could provide a safer, less invasive option for patients with a failed heart valve who are too high-risk for repeat open-heart surgery.
What could go wrong
This is a registry study, not a randomized trial, so results may be less definitive. The procedure still carries risks like stroke or need for a pacemaker, and long-term durability of the new valve is unknown.

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

150 people

The number who actually took part.

Started

May 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention. 2. Estimated high surgical risk (STS predicted risk of mortality ≥ 8 %) or formal contraindication to redo surgical as confirmed by an independent multidisciplinary heart-team review. Exclusion Criteria: 1. Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team. 2. Failed mitral bioprosthesis with estimated post-procedural left-ventricular outflow tract obstruction (LVOTO) gradient ≥ 30 mmHg or LVOTO risk classified as "high" by the independent heart-team. 3. Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure \> 60 mmHg). 4. Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team. 5. More than trivial paravalvular leak around the failing bioprosthesis. 6. Intracardiac thrombus, mass, or vegetation documented by imaging. 7. Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening. 8. Significant coronary artery disease mandating revascularization. 9. Active infective endocarditis within 6 months of screening. 10. Active infection requiring systemic antibiotic therapy at the time of screening. 11. Life expectancy \< 12 months for any non-cardiac condition.

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As listed by the trial registrant

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

Bioprosthesis failure

Contacts and locations

Locations

  • Balance Medical

    Beijing, China

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