Prizvalve® Transcatheter Atrioventricular Valve Replacement Study

Not Applicable

Recruiting

• Conditions: Atrioventricular Annular Calcification; Failed Prosthetic Atrioventricular Valve/ Annulus Repair
• Interventions: Device: Prizvalve® system

• Registration Number: NCT05275088
• Lead Sponsor: Shanghai NewMed Medical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-02
• Study Start: 2022-03-09
• Study First Posted: 2022-03-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18
• Primary Completion: 2024-03
• Study Completion: 2028-06-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Prizvalve® system	Transcatheter atrioventricular valve replacement with the Prizvalve® system

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
All-cause mortality	30 days,1 year	All-cause mortality included cardiac and non-cardiac death.
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.
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.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China