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Recruiting Not applicable

Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

NCT05275088 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2022-03-09
Last updated
2023-11-18

Condition(s) studied

Atrioventricular Annular CalcificationFailed Prosthetic Atrioventricular Valve/ Annulus Repair

Investigational drug(s) / intervention(s)

Prizvalve® system

Prizvalve® system: Transcatheter atrioventricular valve replacement

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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+).

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05275088 on ClinicalTrials.gov ↗ ← All trials in China