An Exploratory Study to Evaluate the Prizvalve® System in Patients With Failing Bioprosthetic Valve

Shanghai NewMed Medical Co., Ltd.1 site in 1 country5 target enrollmentJune 2, 2022

ConditionsFailing Bioprosthetic Valve

Overview

Phase: N/A
Intervention: Not specified
Conditions: Failing Bioprosthetic Valve
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 5
Locations: 1
Primary Endpoint: Composite of all-cause mortality and valve-related reintervention
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve

Detailed Description

The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.

Registry

clinicaltrials.gov

Start Date

June 2, 2022

End Date

June 2, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai NewMed Medical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Failing bioprosthetic valve (≥moderate stenosis and/or ≥moderate regurgitation);
•Age≥18 years old who are not in pregnancy or lactation;
•NYHA Function Class≥ II;
•Patient who is anatomically suitable for the implantation of the Prizvalve® ;
•According to heart team , patient is intermediate or above surgical risk or not suitable for redo open heart surgery of valve replacement due to other severe comorbidities ;
•Heart team agrees valve implantation will likely benefit the patient;
•Patient understands the purpose of the trial and volunteers to participate in, sign the informed consent form and is willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria

•Patients with other valvular diseases that require simultaneous intervention;
•Patients with other heart diseases that require simultaneous intervention;
•Estimated life expectancy \< 12 months;
•Failing valve has moderate and above paravalvular regurgitation;
•Failing valve in unstable ore not structurally intact;
•Increased risk of coronary artery obstruction by prosthetic leaflets of the failing valve;
•Anatomical characteristics that would preclude transcatheter valve implantation;
•Anatomical characteristics that would increase the risk of left ventricular outflow tract (LVOT) obstruction;
•Patient with acute myocardial infarction within 30 days;
•Any therapeutic cardiac operation (excluding previous PCI and pacemaker implantation) is performed within 30 days of the index procedure;