Failing Bioprosthetic ValvesNCT07122050
Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves
A study testing Prizvalve® system Transcatheter valve-in-valve replacement in people with Failing Bioprosthetic Valves, run by Xijing Hospital at 1 site in China.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failing Bioprosthetic Valves
- What is being tested?
- Prizvalve® system Transcatheter valve-in-valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
- Age≥18 years old;
- Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- NYHA Function Class≥ II;
- Patient who is anatomically suitable for the implantation of the Prizvalve®;
- According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
- Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.
Who cannot join
- Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
- Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
- Anatomical features deemed unsuitable for transcatheter implantation.
- Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
- Acute myocardial infarction within 30 days prior to enrollment；
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
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- Active infective endocarditis or any other active infection；
- Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
- Inability to tolerate anticoagulant or antiplatelet therapy；
- Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
- Refusal to undergo emergency cardiac surgery under any circumstances；
- Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
- Investigator-assessed poor compliance that would preclude adherence to protocol requirements；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
Xi'an, Shaanxi
Jian Yang, MD, PhD, +8613892828016, yangjian@fmmu.edu.cn
Meng en Zhai, PhD, +8617782801836, zhaimengen@126.com
About this study
Official title: Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves
The objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.
Read the detailed description
Prospective, single arm, multicenter study
- Conditions
- Failing Bioprosthetic Valves
- Being tested
- Prizvalve® system Transcatheter valve-in-valve replacement
- Keywords
- Prizvalve Valve in Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prizvalve® system Transcatheter valve-in-valve replacementDevice
Transcatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted.
| Study group | Role | What they receive |
|---|---|---|
| 105 Failing Mitral Bioprosthetic Valve | Experimental | Not described Receives: Device: Prizvalve® system Transcatheter valve-in-valve replacement |
| At Least 10 Failing Tricuspid Bioprosthetic Valve | Experimental | Not described Receives: Device: Prizvalve® system Transcatheter valve-in-valve replacement |
| At Least 10 Failing Aortic Bioprosthetic Valve | Experimental | Not described Receives: Device: Prizvalve® system Transcatheter valve-in-valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The primary end point is the 30 days all-cause mortality
Measured: At 30 days
Secondary outcomes (15)
Device success
Device Success Criteria
- Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body;
- The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.
Measured: immediate post-surgical
Procedural success
Procedural Success Criteria
- Correct anatomical positioning of the implanted valve;
- No intra-operative or immediate post-procedural death (≤ 72 h);
- Achievement of the intended therapeutic goal without occurrence of any major intra-operative complication, including but not limited to coronary obstruction, ventricular septal perforation, damage or dysfunction of other native valves, cardiac tamponade, procedure termination, or conversion to open cardiac surgery.
Measured: immediate post-surgical
All-cause mortality
Measured: At 6 months, 1 year
The incidence of rehospitalization
Measured: At 30 days, 6 months, 1 year
The incidence of myocardial infarction
Measured: At 30 days, 6 months, 1 year
The incidence of stroke
Measured: At 30 days, 6 months, 1 year
The incidence of bleeding
Measured: At 30 days, 6 months, 1 year
The incidence of acute kidney injury
Measured: At 30 days, 6 months, 1 year
The incidence of permanent pacemaker implantation
Measured: At 30 days, 6 months, 1 year
The incidence of vascular and access-related complications
Measured: At 30 days, 6 months, 1 year
The incidence of procedure-related complications
Measured: At 30 days, 6 months, 1 year
The incidence of valve dysfunction
Measured: At 30 days, 6 months, 1 year
The incidence of NYHA functional class improvement
the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease
Measured: At 30 days, 6 months, 1 year
The incidence of quality-of-life improvement
By SF-12 Health Survey (Short-Form 12-item Health Survey)
Measured: At 30 days, 6 months, 1 year
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Measured: At 30 days, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failing Bioprosthetic ValvesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Yang, MD, PhD, Principal investigator, Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122050
- Sponsor's protocol ID
- Prizvalve-VIV-202504
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Prizvalve Transcatheter Aortic Valve in Patients With Failing Bioprosthetic Valves
- ClinicalTrials.gov ID
- NCT07122050
- Acronym / sponsor ID
- Prizvalve-VIV-202504
- Conditions
- Failing Bioprosthetic Valves
- Keywords
- Prizvalve Valve in Valve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 14 Aug 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 objective of this study is to evaluate the safety and effectiveness of the Prizvalve transcatheter aortic valve in subjects who are at high or greater risk with failing bioprosthetic valves.
Detailed description
Prospective, single arm, multicenter study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 105 Failing Mitral Bioprosthetic Valve | Experimental | Device: Prizvalve® system Transcatheter valve-in-valve replacement |
| At Least 10 Failing Tricuspid Bioprosthetic Valve | Experimental | Device: Prizvalve® system Transcatheter valve-in-valve replacement |
| At Least 10 Failing Aortic Bioprosthetic Valve | Experimental | Device: Prizvalve® system Transcatheter valve-in-valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for participation:
- Age≥18 years old;
- Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- NYHA Function Class≥ II;
- Patient who is anatomically suitable for the implantation of the Prizvalve®;
Key exclusion criteria (13 listed)
- Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
- Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
- Anatomical features deemed unsuitable for transcatheter implantation.
- Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
- Acute myocardial infarction within 30 days prior to enrollment；
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 |
|---|---|---|
| Prizvalve® system Transcatheter valve-in-valve replacementTranscatheter valve-in-valve replacement procedure was performed according to standard clinical practice. Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system will be attempted. | Device | 105 Failing Mitral Bioprosthetic Valve, At Least 10 Failing Aortic Bioprosthetic Valve, At Least 10 Failing Tricuspid Bioprosthetic Valve |
Primary outcome
All-cause mortality
Time frame: At 30 days
The primary end point is the 30 days all-cause mortality
15 secondary outcomes
Device success
Time frame: immediate post-surgical
Procedural success
Time frame: immediate post-surgical
All-cause mortality
Time frame: At 6 months, 1 year
The incidence of rehospitalization
Time frame: At 30 days, 6 months, 1 year
The incidence of myocardial infarction
Time frame: At 30 days, 6 months, 1 year
The incidence of stroke
Time frame: At 30 days, 6 months, 1 year
The incidence of bleeding
Time frame: At 30 days, 6 months, 1 year
The incidence of acute kidney injury
Time frame: At 30 days, 6 months, 1 year
The incidence of permanent pacemaker implantation
Time frame: At 30 days, 6 months, 1 year
The incidence of vascular and access-related complications
Time frame: At 30 days, 6 months, 1 year
The incidence of procedure-related complications
Time frame: At 30 days, 6 months, 1 year
The incidence of valve dysfunction
Time frame: At 30 days, 6 months, 1 year
The incidence of NYHA functional class improvement
Time frame: At 30 days, 6 months, 1 year
The incidence of quality-of-life improvement
Time frame: At 30 days, 6 months, 1 year
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: At 30 days, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) would not be shared, according to local authority data privacy policy.
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.
Jian Yang, MD, PhD principal investigator
Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prizvalve® system Transcatheter valve-in-valve replacement in people with Failing Bioprosthetic Valves, run by Xijing Hospital 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 7 inclusion and 13 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: opening soon, as of the sponsor's last update on 14 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Yang, MD, PhD (+8613892828016, yangjian@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: At 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.