Bioprosthesis FailureVIVNCT07174531
Renato® Transcatheter Valve-in-Valve System Multicenter Registry Trial (China)
A study testing Transcatheter valve in Valve implantation in people with Bioprosthesis Failure, run by Beijing Balance Medical Technology Co., Ltd at 1 site in China.
Trial summary
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bioprosthesis Failure
- What is being tested?
- Transcatheter valve in Valve implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to 28 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
- 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.
Who cannot join
- Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
- 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.
- Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure > 60 mmHg).
- Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
- More than trivial paravalvular leak around the failing bioprosthesis.
- Intracardiac thrombus, mass, or vegetation documented by imaging.
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- Myocardial infarction, coronary-stent implantation, cardiac rhythm-device implantation, stroke, or transient ischemic attack within 30 days before screening.
- Significant coronary artery disease mandating revascularization.
- Active infective endocarditis within 6 months of screening.
- Active infection requiring systemic antibiotic therapy at the time of screening.
- Life expectancy < 12 months for any non-cardiac condition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Renato® Transcatheter Valve-in-Valve System
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. A new bioprosthetic valve is delivered via a transcatheter approach and positioned inside the failing valve, restoring valve function .
- Conditions
- Bioprosthesis Failure
- Being tested
- Transcatheter valve in Valve implantation
- Keywords
- Valve-in-Valve, Renato, Aortic Valve Replacement, Tricuspid Valve Replacement, Mitral Valve Replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter valve in Valve implantationProcedure or surgery
Transcatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis Failure Valve Replacement | Experimental | Transcatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement. Receives: Procedure: Transcatheter valve in Valve implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
Cardiac and non-cardiac mortality will be captured for all enrolled patients.
Measured: 12 months.
Secondary outcomes (1)
Safety Parameters
Incidence of major adverse cardiovascular events (MACE), defined as a composite of myocardial infarction, stroke, permanent pacemaker implantation, or rehospitalization due to heart failure,
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start25 May 2021
- Primary completion20 May 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bioprosthesis FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Balance Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174531
- Sponsor's protocol ID
- BRYL2020A
- Acronym
- VIV
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Yang Y, Song W, Feng D, Yan Y, Wang C, Wei L. Transcatheter tricuspid valve-in-valve implantation for degenerated surgical bioprosthesis. Catheter Cardiovasc Interv. 2023 Feb 1;101(2):442-448. doi: 10.1002/ccd.30554. Epub 2023 Jan 8.
PubMed 36617381
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial to Evaluate the Efficacy and Safety of the Renato® Transcatheter Valve-in-Valve System
- ClinicalTrials.gov ID
- NCT07174531
- Acronym / sponsor ID
- VIV / BRYL2020A
- Conditions
- Bioprosthesis Failure
- Keywords
- Valve-in-Valve, Renato, Aortic Valve Replacement, Tricuspid Valve Replacement, Mitral Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Beijing Balance Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Renato® transcatheter valve-in-valve system, developed by Balance Medical, is undergoing a multicenter registry trial across China. The study enrolls patients whose previously implanted surgical or transcatheter bioprosthetic valves have deteriorated and who are at high risk for repeat open-heart surgery. A new bioprosthetic valve is delivered via a transcatheter approach and positioned inside the failing valve, restoring valve function .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthesis Failure Valve Replacement | Experimental | Procedure: Transcatheter valve in Valve implantationTranscatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pre-existing bioprosthetic valve with clinically significant structural deterioration (≥ moderate stenosis or regurgitation) in the mitral, aortic, or tricuspid position, mandating re-intervention.
- 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.
Key exclusion criteria (11 listed)
- Small true internal diameter of the failing bioprosthesis deemed unsuitable for valve-in-valve therapy by the independent heart-team.
- 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.
- Failed tricuspid bioprosthesis with concomitant severe pulmonary hypertension (systolic pulmonary artery pressure > 60 mmHg).
- Any additional native or prosthetic valve lesion requiring concomitant surgical intervention, as determined by the independent heart-team.
- More than trivial paravalvular leak around the failing bioprosthesis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter valve in Valve implantationTranscatheter valve-in-valve implantation for patients with degenerated aortic/mitral/tricuspid bioprosthetic valves who are at high-risk to redo surgical valve replacement. | Procedure or surgery | Prosthesis Failure Valve Replacement |
Primary outcome
All-cause death
Time frame: 12 months.
Cardiac and non-cardiac mortality will be captured for all enrolled patients.
1 secondary outcome
Safety Parameters
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Results publication: PubMed 36617381Chen J, Yang Y, Song W, Feng D, Yan Y, Wang C, Wei L. Transcatheter tricuspid valve-in-valve implantation for degenerated surgical bioprosthesis. Catheter Cardiovasc Interv. 2023 Feb 1;101(2):442-448. doi: 10.1002/ccd.30554. Epub 2023 Jan 8.
- Individual participant dataSharing planned: No
Related trials for Bioprosthesis Failure
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter valve in Valve implantation in people with Bioprosthesis Failure, run by Beijing Balance Medical Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.