An Exploratory Study to Evaluate the Prizvalve® System in Patients With Severe Atrioventricular Annular Calcification or Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Shanghai NewMed Medical Co., Ltd.1 site in 1 country15 target enrollmentMarch 9, 2022

ConditionsAtrioventricular Annular Calcification Failed Prosthetic Atrioventricular Valve/ Annulus Repair

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrioventricular Annular Calcification
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 15
Locations: 1
Primary Endpoint: Technical success
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 9, 2022

End Date

June 10, 2028

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

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Technical success

Time Frame: 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+).