Failing Bioprosthetic ValveNCT05652062
Prizvalve® Transcatheter Valve-in-Valve Implantation Exploratory Study
A study testing Prizvalve® system in people with Failing Bioprosthetic Valve, run by Shanghai NewMed Medical Co., Ltd. at 1 site in China.
Trial summary
The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failing Bioprosthetic Valve
- What is being tested?
- Prizvalve® system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2022to 2 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- Age≥18 years old who are not in pregnancy or lactation;
- NYHA Function Class≥ II;
- Patient who is anatomically suitable for the implantation of the Prizvalve® ;
- According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
- Heart team agrees valve implantation will likely benefit the patient;
- 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
- Patients with other valvular diseases that require simultaneous intervention;
- Patients with other heart diseases that require simultaneous intervention;
- Estimated life expectancy < 12 months;
- Failing valve has moderate and above paravalvular regurgitation;
- Failing valve in unstable ore not structurally intact;
- Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
Show all 21Show fewer
- Anatomical characteristics that would preclude transcatheter valve implantation;
- Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
- Patient with acute myocardial infarction within 30 days;
- Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
- Patient with hypertrophic cardiomyopathy with obstruction;
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Patients with active infective endocarditis or other active infections;
- Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 20%;
- Patients who cannot tolerate anticoagulant or antiplatelet therapy;
- Patients with severe untreated coronary artery stenosis requiring revascularization;
- Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;
- Patients who refuse surgical treatment in emergency situations under any circumstances;
- Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;
- Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
- The investigator judged that patient with poor compliance and could not complete the study as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Wang chunsheng, Chief, (86)021-64041990 ext. 2512, cswang@medmail.com.cn
About this study
Official title: An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve
The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve
Read the detailed description
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
- Conditions
- Failing Bioprosthetic Valve
- Being tested
- Prizvalve® system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prizvalve® systemDevice
Transcatheter valve-in-valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Prizvalve® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause mortality and valve-related reintervention
Measured: 1 year
Secondary outcomes (4)
Technical success
- Freedom from death;
- Successful vascular delivery and retrieval of transcatheter valve delivery system;
- Correct position of transcatheter valve;
- No need for any emergency surgery or re-intervention (including device-related and surgical approach-related);
- Adequate performance of prosthesis (No moderate or greater stenosis or regurgitation).
Measured: 30 days
Procedural Success
- Device success;
- No severe complications of the following: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention.
Measured: 30 days
Device success
- Freedom from stroke;
- Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis);
- No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related);
- No prosthetic valve stenosis；
- Prosthetic valve regurgitation <2+ (including central leakage and paravalvular leakage), and no related hemolysis;
- LVOT pressure gradient increased <20mmHg.
Measured: 30 days
All-cause mortality
All-cause mortality included cardiac，non-cardiac death and other ominous death.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start2 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failing Bioprosthetic ValveStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652062
- Sponsor's protocol ID
- Prizvalve-VIV-2022
- Status last verified
- Nov 2023
- First submitted
- 8 Dec 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve
- ClinicalTrials.gov ID
- NCT05652062
- Acronym / sponsor ID
- Prizvalve-VIV-2022
- Conditions
- Failing Bioprosthetic Valve
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 15 Dec 2022 (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 primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve
Detailed description
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Prizvalve® system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
- Age≥18 years old who are not in pregnancy or lactation;
- NYHA Function Class≥ II;
- Patient who is anatomically suitable for the implantation of the Prizvalve® ;
- According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
Key exclusion criteria (21 listed)
- Patients with other valvular diseases that require simultaneous intervention;
- Patients with other heart diseases that require simultaneous intervention;
- Estimated life expectancy < 12 months;
- Failing valve has moderate and above paravalvular regurgitation;
- Failing valve in unstable ore not structurally intact;
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® systemTranscatheter valve-in-valve replacement | Device | Treatment |
Primary outcome
Composite of all-cause mortality and valve-related reintervention
Time frame: 1 year
4 secondary outcomes
Technical success
Time frame: 30 days
Procedural Success
Time frame: 30 days
Device success
Time frame: 30 days
All-cause mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
Related trials for Failing Bioprosthetic Valve
Not yet recruiting
Prizvalve Transcatheter Aortic Valve in Failing Bioprosthetic Valves
Failing Bioprosthetic Valves
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.
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 in people with Failing Bioprosthetic Valve, run by Shanghai NewMed Medical 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause mortality and valve-related reintervention (time frame: 1 year). 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 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.