Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Study Overview
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Brief Summary
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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
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The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Official Title
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An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Conditions
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Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Intervention / Treatment
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* Device: Prizvalve® system


Participation Criteria
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Eligibility Criteria
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1. Inclusion criteria for patients with severe atrioventricular valve annular calcification: Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed); Patient with symptoms, and NYHA Functional Class≥Ⅱ; 18 years and older who is not in pregnancy or lactation; Life expectancy>12 months; Patient who is anatomically suitable for transcatheter atrioventricular valve replacement; According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; 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; 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. 2. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair: The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis; 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); 18 years and older who is not in pregnancy or lactation; Patient who is anatomically suitable for transcatheter atrioventricular valve replacement; According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement; 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; Patient with high risk of routine surgery (STS>8%) or severe comorbidities that is not suitable for surgery. Exclusion criteria: Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment; Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure; Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation; Patient with hypertrophic cardiomyopathy with obstruction; Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; Echocardiographic evidence of intracardiac mass, thrombus or vegetation; Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure; Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy; Active stage of infective endocarditis or other active infection; Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack; Patient with poor compliance and could not complete the study as required.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Transcatheter atrioventricular valve replacement with the Prizvalve® system | Device: Prizvalve® system<br>* Transcatheter atrioventricular valve replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Definition: Freedom from death; Successful vascular delivery and retrieval of transcatheter valve delivery system; Correct position of transcatheter valve; No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); Adequate performance of prosthesis (mean pressure gradient (MVG) <10mmHg, valve regurgitation <2+). | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Success | Device success; No SAE's including: death; stroke; life threatening bleeding; major vascular complications; secondary severe cardiac organic disease (eg: aortic dissection, apical aneurysm formation, left ventricular outflow tract obstruction, etc.); stage 2 or 3 AKI; MI or coronary ischemia requiring PCI or CABG; severe hypotension; heart failure or respiratory failure requiring high-dose vasoactive drugs/or cardiac mechanical assist devices; any valve-related dysfunction including migration, thrombosis, or other complication requiring surgery or repeat intervention. | 30 days,1 year | 
| Device success | Definitions: Freedom from stroke; Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); No atrioventricular valve stenosis (mean pressure gradient <10mmHg); Atrioventricular valve regurgitation <2+ (including central leakage and paravalvular leakage), and no related hemolysis; LVOT pressure gradient increased <20mmHg. | 30 days,1 year | 
| All-cause mortality | All-cause mortality included cardiac and non-cardiac death. | 30 days,1 year |