Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

NCT ID: NCT05275088

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2028-06-10

Brief Summary

To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.

Detailed Description

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

Conditions

Atrioventricular Annular Calcification; Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Study Design

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

Study Groups

Treatment

Transcatheter atrioventricular valve replacement with the Prizvalve® system

Group Type: EXPERIMENTAL

Prizvalve® system

Intervention Type: DEVICE

Transcatheter atrioventricular valve replacement

Interventions

Prizvalve® system

Transcatheter atrioventricular valve replacement

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);

2. Patient with symptoms, and NYHA Functional Class≥Ⅱ;

3. 18 years and older who is not in pregnancy or lactation;

4. Life expectancy>12 months;

5. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;

6. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;

7. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;

8. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery, or with severely calcified valve annulus that cannot be operated.

1. The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;

2. The patient is symptomatic with NYHA Functional Class≥II or hemolytic anemia requiring blood transfusion (no other causes of hemolytic anemia were found after examination);

3. 18 years and older who is not in pregnancy or lactation;

4. Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;

5. According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;

6. The patient can understand the purpose of the trial, voluntarily participate in and sign the informed consent form, and is willing to accept relevant examinations and clinical follow-ups;

7. Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery.

Exclusion Criteria

1. Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;

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

3. Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;

4. Patient with hypertrophic cardiomyopathy with obstruction;

5. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;

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

7. Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;

8. Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;

9. Active stage of infective endocarditis or other active infection;

10. Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;

11. 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

P-valve-2021-12

Identifier Type: -

Identifier Source: org_study_id