Multicenter Pivotal Study to Evaluate the Treatment of Severe Aortic Valve Stenosis With Next-Generation Venus-Vitae Transcatheter Heart Valve (THV) System

Venus MedTech (HangZhou) Inc.0 sites150 target enrollmentOctober 31, 2023

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Venus MedTech (HangZhou) Inc.
Enrollment: 150
Primary Endpoint: The rate of deaths at the one-year follow-up visit post procedure
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.

Detailed Description

This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.

Registry

clinicaltrials.gov

Start Date

October 31, 2023

End Date

June 30, 2029

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Venus MedTech (HangZhou) Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years
•Patients with the symptoms of severe aortic stenosis
•Severe aortic stenosis (AS, grade 3+), defined as AVA ≤ 1 cm2 (AVAi ≤ 0.6 cm2/m3) or Vmax ≥ 4.0 m/s or MPG ≥ 40 mmHg determined by echocardiography
•Patients deemed for cardiac intervention by a heart team
•Patients of all surgical risk categories can be enrolled in this study, but should follows local medical practices and regulatories.
•Patients or their legal reprensentatives are willing to participate in the study and provide written informed consent, and agree to follow the follow-up requirements

Exclusion Criteria

•A subject meeting any of the following criteria shall be excluded:
•Co-morbidities
•Previous mechanical or biological aortic valve replacement
•Untreated mitral, tricuspid or pulmonary valve diseases requiring procedural intervention
•Acute myocardial infact within 30 days prior to index procedure
•Untreated clinical significant coronary artery disease requiring revascularization
•Any therapeutic invasive cardiac procedure performed within 30 days (or drug-eluting coronary stent/scaffold implant within 6 months)
•Sever symptomatic carotid artery stenosis
•Stroke or TIA within 3 months or Modified Rankin Scale ≥ 4 disability
•Chronic kidney disease (eGFR\<30 mL/min/1.73m2)

Outcomes

Primary Outcomes

The rate of deaths at the one-year follow-up visit post procedure

Time Frame: 1 Years

All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)

Acceptable Hemodynamic Performance at 30 days

Time Frame: 30 Days

Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: * Mean gradient \< 20mmHg * Less than moderate aortic regurgitation (perivalvular and transvalvular)

Secondary Outcomes

The rate of device success is defined as the following(Up to 1 week)
The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:(Up to 1 week)
The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT(30-Days)
New York Heart Association (NYHA) classification during follow-up(5 Years)
Technical success is defined as the following(During the Procedure)
The rate of freedom from mild or greater PVL by echocardiogram during follow-up(5 Years)
Occurrence of the following adverse events echocardiogram during follow-up(5 Years)
The rate of freedom from severe coronary overlap assessed by post-implant angiogram(immediately after the procedure)