Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves

August 10, 2025 updated by: Xijing Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective, single arm, multicenter study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation:

  1. Age≥18 years old;
  2. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
  3. NYHA Function Class≥ II;
  4. Patient who is anatomically suitable for the implantation of the Prizvalve®;
  5. According to heart team , patient is at high or greater surgical risk or not suitable for redo open heart surgery of valve replacement;
  6. 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.

Exclusion Criteria:

  1. Moderate or greater paravalvular regurgitation of the degenerated bioprosthetic valve；
  2. Degenerated valve that cannot be securely fixed within the native annulus or exhibits structural incompleteness；
  3. Anatomical features deemed unsuitable for transcatheter implantation.
  4. Anatomical features that significantly increase the risk of left ventricular outflow tract (LVOT) obstruction；
  5. Acute myocardial infarction within 30 days prior to enrollment；
  6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation；
  7. Active infective endocarditis or any other active infection；
  8. Severe right ventricular dysfunction or severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20 %；
  9. Inability to tolerate anticoagulant or antiplatelet therapy；
  10. Cerebrovascular accident within 3 months prior to enrollment, excluding transient ischemic attack；
  11. Refusal to undergo emergency cardiac surgery under any circumstances；
  12. Participation in another drug or device clinical trial that has not yet reached its primary endpoint as of the time of enrollment；
  13. Investigator-assessed poor compliance that would preclude adherence to protocol requirements；

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 105 Failing Mitral Bioprosthetic Valve
Device: Prizvalve® system Transcatheter valve-in-valve replacement
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.
Experimental: At Least 10 Failing Tricuspid Bioprosthetic Valve
Device: Prizvalve® system Transcatheter valve-in-valve replacement
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.
Experimental: At Least 10 Failing Aortic Bioprosthetic Valve
Device: Prizvalve® system Transcatheter valve-in-valve replacement
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: At 30 days
The primary end point is the 30 days all-cause mortality
At 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success
Time Frame: immediate post-surgical

Device Success Criteria

  1. Successful vascular access, delivery, deployment and implantation of the study device, with complete removal of the delivery system from the body;
  2. The implanted prosthetic valve achieves the intended haemodynamic performance, defined as the absence of moderate or greater prosthetic valve stenosis or regurgitation.
immediate post-surgical
Procedural success
Time Frame: immediate post-surgical

Procedural Success Criteria

  1. Correct anatomical positioning of the implanted valve;
  2. No intra-operative or immediate post-procedural death (≤ 72 h);
  3. 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.
immediate post-surgical
All-cause mortality
Time Frame: At 6 months, 1 year
At 6 months, 1 year
The incidence of rehospitalization
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of myocardial infarction
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of stroke
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of bleeding
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of acute kidney injury
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of permanent pacemaker implantation
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of vascular and access-related complications
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of procedure-related complications
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of valve dysfunction
Time Frame: At 30 days, 6 months, 1 year
At 30 days, 6 months, 1 year
The incidence of NYHA functional class improvement
Time Frame: At 30 days, 6 months, 1 year
the New York Heart Association to quantify the severity of functional limitation and symptoms attributable to cardiac disease
At 30 days, 6 months, 1 year
The incidence of quality-of-life improvement
Time Frame: At 30 days, 6 months, 1 year
By SF-12 Health Survey (Short-Form 12-item Health Survey)
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
At 30 days, 6 months, 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jian Yang, MD, PhD, Department of Cardiovascular Surgery of Xijing Hospital, Air Force Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Prizvalve-VIV-202504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) would not be shared, according to local authority data privacy policy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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