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Aortic Valve StenosisNCT05864456

Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

A study testing Prizvalve Pro™ transcatheter aortic valve system in people with Aortic Valve Stenosis, run by Shanghai NewMed Medical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Prizvalve Pro™ transcatheter aortic valve system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteChina
Study dates
5 Jul 2023to May 2028
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 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age ≥ 65 years ;
  • Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area<1.0cm², or AVA <0.5cm² /m²);
  • Cardiac function NYHA ≥ II;
  • Life expectancy> 12 months;
  • Patients who are anatomically suitable for transcatheter aortic valve implantation;
  • Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
  • Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.

Who cannot join

  • Acute myocardial infarction occurred within 1 month before this treatment;
  • Congenital unicuspid aortic valve;
  • Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
  • Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);
  • Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
  • Untreated severe coronary artery stenosis that requires revascularization;
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  • Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
  • Patients who need emergency surgery for any reason;
  • Patients with hypertrophic cardiomyopathy with obstruction;
  • Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
  • Patients with left ventricular outflow tract obstruction;
  • A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
  • Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
  • Patients who are unable to receive anticoagulation or antiplatelet therapy;
  • Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
  • Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
  • Active infective endocarditis or other active infections;
  • 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. Contact the study team or a site near you to ask about taking part.

Chunyang Wang contact

(86)-21-20788668

wang_chunyang@newmed.cn

Xuyang Xie contact

(86)-21-20788668

China1 site, 1 recruiting

  • Shanghai NewMed Medical Co., Ltd.

    Shanghai

    Xuyang Xie

    Recruiting

Other trials in China

About this study

Official title: Evaluation of the Safety and Efficacy of the Prizvalve Pro™ Transcatheter Aortic Valve System in the Treatment of Patients With Severe Aortic Valve Stenosis Disease at High Surgical Risk

The purpose of this clinical trial is to evaluate the safety and efficacy of the Prizvalve Pro™ transcatheter aortic valve system in the treatment of patients with severe aortic stenosis who are at high risk of surgery or who are not suitable for surgery.

Read the detailed description

This study is a multicenter, single-arm, prospective clinical study.

Being tested
Prizvalve Pro™ transcatheter aortic valve system
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prizvalve Pro™ transcatheter aortic valve systemDevice

    Transcatheter Aortic Valve Replacement

Study groups in NCT05864456
Study groupRoleWhat they receive
Transcatheter aortic valve replacementExperimentalTranscatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system
Receives: Device: Prizvalve Pro™ transcatheter aortic valve system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite endpoint event rate at 30 days

    Composite endpoint event includes all-cause death, stroke, myocardial infarction, permanent pacemaker implantation, serious vascular and access-related complications, surgical intervention for aortic valve reoperation, valve-in-valve surgery.

    Measured: 30 days after procedure

Secondary outcomes (15)

  1. Device success rate

    Device success is defined as

    1. The device enters the vascular approach, be transported, released and implanted successfully, and the delivery system is removed from the body successfully;
    2. The implanted valve achieves the desired efficacy (mean transvalvular pressure difference <20 mmHg or peak flow velocity <3 m/s in the aortic valve, no severe prosthetic aortic regurgitation or perivalvular leak).

    Measured: Immediately after procedure

  2. Procedural success rate

    Procedure success is defined as

    1. Implantation of ≤2 valves, with the implanted valves placed in the appropriate anatomic position;
    2. No intraoperative or immediate postoperative mortality;
    3. The intended purpose of the procedure was achieved without serious intraoperative complications (coronary occlusion, septal perforation, mitral valve damage or incompetence, pericardial tamponade, surgical termination, and open-heart surgical treatment for cardiac surgery).

    Measured: Immediately after procedure

  3. Delivery system and component performance evaluation

    Delivery system performance evaluation includes delivery, transvalve, release positioning, balloon filling and retrieval, visibility, and retrieval performance.

    (For each assessment: 1-4 points；1=excellent, 2=good, 3=fair, 4=poor).

    Measured: Immediately after procedure

  4. Valve function

    Valve function includes aortic orifice area, transvalvular pressure difference, valvular regurgitation, and perivalvular leakage.

    Measured: Immediately after procedure, 1 day of discharge, 30 days, 1 year

  5. Improvement in cardiac function

    Cardiac function is based on the New York Heart Association (NYHA) classification scheme.

    Measured: 1 day of discharge, 30 days, 1-5 year

  6. Improvement in quality of life

    The SF-12 rating scale is used to assess quality of life.

    Measured: 30 days, 1 year

  7. Incidence of all-cause mortality

    Rate of all-cause mortality during the trial. All-cause mortality includes cardiovascular morality and non-cardiovascular morality.

    Measured: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year

  8. Incidence of myocardial infarction

    Rate of patients with myocardial infarction during the trial.

    Measured: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year

  9. Incidence of disabling stroke

    Rate of patients with disabling stroke during the trial.

    Measured: 1 day of discharge, 30 days, 1-5 year

  10. Incidence of permanent pacemaker implantation

    Rate of patients with permanent pacemaker implantation during the trial.

    Measured: 1 day of discharge, 30 days, 1-5 year

  11. Incidence of serious vascular and access-related complications

    Rate of patients with serious vascular and access-related complications during the trial.

    Measured: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year

  12. Incidence of serious bleeding

    Rate of patients with serious bleeding during the trial.

    Measured: 1 day of discharge, 30 days, 1-5 year

  13. Incidence of acute kidney injury

    Rate of patients with acute kidney injury during the trial.

    Measured: 1 day of discharge, 30 days, 1-5 year

  14. Incidence of major cardiovascular and cerebrovascular adverse events

    Incidence of MACCE during the trial. MACCE is defined as death, stroke, myocardial infarction, arrhythmia, conduction block, and aortic valve reoperation (interventional or surgical).

    Measured: 1 day of discharge, 30 days, 1-5 year

  15. Incidence of other TAVI-related complications

    Rate of patients with other TAVI-related complications during the trial. Other TAVI-related complications include conversion to surgery, valve-in-valve implantation, accidental cardiopulmonary mechanical assistance, coronary occlusion, ventricular septal perforation, mitral valve damage or loss of function, pericardial tamponade, endocarditis, valvular thrombosis, valvular ectopic (migration, embolization, erroneous release), etc.

    Measured: Immediately after procedure, 1 day of discharge, 30 days, 1-5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2023
  2. Study start5 Jul 2023
  3. Primary completionJun 2024 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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
73 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05864456
Sponsor's protocol ID
Prizvalve Pro-2023
Status last verified
Nov 2023
First submitted
9 May 2023
Last updated
18 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Prizvalve Pro™ transcatheter aortic valve system in people with Aortic Valve Stenosis, 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 20 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: looking for participants now, 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?

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 Chunyang Wang ((86)-21-20788668, wang_chunyang@newmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint event rate at 30 days (time frame: 30 days after procedure). 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 NCT05864456.

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.

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