Status:
RECRUITING
Prizvalve® Transcatheter Atrioventricular Valve Replacement Study
Lead Sponsor:
Shanghai NewMed Medical Co., Ltd.
Collaborating Sponsors:
Shanghai Zhongshan Hospital
Conditions:
Atrioventricular Annular Calcification
Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05275088
Start Date
March 9 2022
End Date
June 10 2028
Last Update
November 18 2023
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032