Prizvalve Pro™ Transcatheter Aortic Valve Replacement Study

NCT ID: NCT05864456

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-05
• Study Completion Date: 2028-05-31

Brief 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.

Detailed Description

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

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement with Prizvalve Pro™ transcatheter aortic valve system

Group Type: EXPERIMENTAL

Prizvalve Pro™ transcatheter aortic valve system

Intervention Type: DEVICE

Transcatheter Aortic Valve Replacement

Interventions

Prizvalve Pro™ transcatheter aortic valve system

Transcatheter Aortic Valve Replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 65 years ;

2. 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);

3. Cardiac function NYHA ≥ II;

4. Life expectancy> 12 months;

5. Patients who are anatomically suitable for transcatheter aortic valve implantation;

6. 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;

7. 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.

Exclusion Criteria

1. Acute myocardial infarction occurred within 1 month before this treatment;

2. Congenital unicuspid aortic valve;

4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (>3+);

5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;

6. Untreated severe coronary artery stenosis that requires revascularization;

7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;

8. Patients who need emergency surgery for any reason;

9. Patients with hypertrophic cardiomyopathy with obstruction;

10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) <20%;

11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;

12. Patients with left ventricular outflow tract obstruction;

13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;

14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;

15. Patients who are unable to receive anticoagulation or antiplatelet therapy;

16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;

17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;

18. Active infective endocarditis or other active infections;

19. 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;

20. The investigator judged that patient with poor compliance and could not complete the study as required.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The General Hospital of Northern Theater Command

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Shanghai NewMed Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaling Han, Professor

Role: STUDY_CHAIR

Principal coordinating investigator

Mao Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

coordinating investigator

Kai Xu, Professor

Role: STUDY_DIRECTOR

coordinating investigator

Locations

Shanghai NewMed Medical Co., Ltd.

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Chunyang Wang

Role: CONTACT

wang_chunyang@newmed.cn

(86)-21-20788668

Xuyang Xie

Role: CONTACT

(86)-21-20788668

Facility Contacts

Xuyang Xie

Role: primary

Other Identifiers

Prizvalve Pro-2023

Identifier Type: -

Identifier Source: org_study_id