Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

NCT05275088 | Recruiting DMC

• 1 other identifier: P-valve-2021-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Annular Calcification; Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Outcome Measures

Primary Outcomes (1)

• Technical success

  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+).

  30 days

Secondary Outcomes (3)

• Procedural Success

  30 days,1 year

• Device success

  30 days,1 year

• All-cause mortality

  30 days,1 year

Study Arms (1)

Treatment

EXPERIMENTAL

Transcatheter atrioventricular valve replacement with the Prizvalve® system

Device: Prizvalve® system

Interventions

Prizvalve® system DEVICE

Transcatheter atrioventricular valve replacement

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Atrioventricular valve annular calcification with moderate or severe atrioventricular valve disease (stenosis, regurgitation, or mixed);
• Patient with symptoms, and NYHA Functional Class≥Ⅱ;
• 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.
• 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);
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 11, 2022
• Study Start: March 9, 2022
• Primary Completion: March 1, 2024
• Study Completion (Estimated): June 10, 2028
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)