Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Transcatheter atrioventricular valve replacement with the Prizvalve® system |
Device: Prizvalve® system
Transcatheter atrioventricular valve replacement
|
Outcome Measures
Primary Outcome Measures
- Technical success [30 days]
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+).
Secondary Outcome Measures
- Procedural Success [30 days,1 year]
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.
- Device success [30 days,1 year]
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.
- All-cause mortality [30 days,1 year]
All-cause mortality included cardiac and non-cardiac death.
Eligibility Criteria
Criteria
-
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);
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Patient with symptoms, and NYHA Functional Class≥Ⅱ;
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18 years and older who is not in pregnancy or lactation;
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Life expectancy>12 months;
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Patient who is anatomically suitable for transcatheter atrioventricular valve replacement;
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According to the evaluation of the heart team, the patient can benefit from transcatheter atrioventricular valve replacement;
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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;
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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.
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Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:
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The patient has undergone atrioventricular valve replacement or valve annulus repair in the past, accompanied by severe atrioventricular valve regurgitation or stenosis;
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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);
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18 years and older who is not in pregnancy or lactation;
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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:
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Evidence of an acute myocardial infarction <1 month(30 days) before the intended treatment;
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Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;
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Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation;
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Patient with hypertrophic cardiomyopathy with obstruction;
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Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%;
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Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
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Acute peptic ulcer or upper gastrointestinal bleeding within 3 months prior to procedure;
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Allergy to cobalt-chromium alloy or contrast agent; inability to tolerate anticoagulation and antiplatelet therapy;
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Active stage of infective endocarditis or other active infection;
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Cerebrovascular accident within 3 months prior to procedure, excluding transient ischemic attack;
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Patient with poor compliance and could not complete the study as required.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhongshan Hospital | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Shanghai NewMed Medical Co., Ltd.
- Shanghai Zhongshan Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P-valve-2021-12