Prizvalve® Transcatheter Valve-in-Valve Implantation Exploratory Study

NCT ID: NCT05652062

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2024-06-02

Brief 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

Detailed Description

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Conditions

Failing Bioprosthetic Valve

Study Design

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

Study Groups

Treatment

Group Type: EXPERIMENTAL

Prizvalve® system

Intervention Type: DEVICE

Transcatheter valve-in-valve replacement

Interventions

Prizvalve® system

Transcatheter valve-in-valve replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);

2. Age≥18 years old who are not in pregnancy or lactation;

3. NYHA Function Class≥ II;

4. Patient who is anatomically suitable for the implantation of the Prizvalve® ;

5. 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 ;

6. Heart team agrees valve implantation will likely benefit the patient;

7. 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. Patients with other valvular diseases that require simultaneous intervention;

2. Patients with other heart diseases that require simultaneous intervention;

3. Estimated life expectancy < 12 months;

4. Failing valve has moderate and above paravalvular regurgitation;

5. Failing valve in unstable ore not structurally intact;

6. Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;

7. Anatomical characteristics that would preclude transcatheter valve implantation;

8. Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;

9. Patient with acute myocardial infarction within 30 days;

10. Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;

11. Patient with hypertrophic cardiomyopathy with obstruction;

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

13. Patients with active infective endocarditis or other active infections;

14. Patients with severe right ventricular dysfunction, or severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) < 20%;

15. Patients who cannot tolerate anticoagulant or antiplatelet therapy;

16. Patients with severe untreated coronary artery stenosis requiring revascularization;

17. Patients with cerebrovascular accident within 3 months, excluding transient ischemic attack;

18. Patients who refuse surgical treatment in emergency situations under any circumstances;

19. Patients who have severely disabled Alzheimer's disease and inability to take care of themselves;

20. 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;

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: collaborator

Shanghai NewMed Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Wang chunsheng, Chief

Role: primary

cswang@medmail.com.cn

(86)021-64041990 ext. 2512

Other Identifiers

Prizvalve-VIV-2022

Identifier Type: -

Identifier Source: org_study_id