Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Shanghai NewMed Medical

Status: Enrolling

Conditions: Failed Prosthetic Atrioventricular Valve/ Annulus Repair; Atrioventricular Annular Calcification

Treatments: Device: Prizvalve® system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05275088

P-valve-2021-12

Details and patient eligibility

About

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

Full description

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion criteria for patients with severe atrioventricular valve annular calcification:

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

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

4. 18 years and older who is not in pregnancy or lactation;

5. Life expectancy>12 months;

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

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

8. 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;

9. 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.

10. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:

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

12. 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);

13. 18 years and older who is not in pregnancy or lactation;

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

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

16. 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;

17. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Treatment

Experimental group

Description:

Transcatheter atrioventricular valve replacement with the Prizvalve® system

Treatment:

Device: Prizvalve® system