Atrioventricular Annular Calcification, Failed Prosthetic Atrioventricular Valve/ Annulus Repair
Conditions
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.
Interventions
DEVICEPrizvalve® system
Transcatheter atrioventricular valve replacement
Sponsors
Shanghai Zhongshan Hospital
Shanghai NewMed Medical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Inclusion criteria for patients with severe atrioventricular valve annular calcification: 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. 2\. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair: 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 30 days | Definition: 1. Freedom from death; 2. Successful vascular delivery and retrieval of transcatheter valve delivery system; 3. Correct position of transcatheter valve; 4. No need for any emergency surgery or re-intervention (including device-related and surgical approach-related); 5. Adequate performance of prosthesis (mean pressure gradient (MVG) \<10mmHg, valve regurgitation \<2+). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | 30 days,1 year | 1. Device success; 2. 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: 1. Freedom from stroke; 2. Prosthetic heart valve function is normal (including no displacement, calcification, thrombosis, hemolysis, or endocarditis); 3. No need for any emergency surgery or secondary intervention (including device-related and surgical approach-related); 4. No atrioventricular valve stenosis (mean pressure gradient \<10mmHg); 5. Atrioventricular valve regurgitation \<2+ (including central leakage and paravalvular leakage), and no related hemolysis; 6. LVOT pressure gradient increased \<20mmHg. |
| All-cause mortality | 30 days,1 year | All-cause mortality included cardiac and non-cardiac death. |
Countries
China
Outcome results
None listed