Efficacy and Safety of the J-Valve Transcatheter Aortic Valve Replacement System in Patients With Aortic Regurgitation Disease

Genesis Medtech Corporation15 sites in 1 country120 target enrollmentOctober 14, 2022

ConditionsDiseases of Aortic Valve Aortic Regurgitation Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diseases of Aortic Valve
Sponsor: Genesis Medtech Corporation
Enrollment: 120
Locations: 15
Primary Endpoint: Cumulative all-cause mortality
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic regurgitation disease who are at high or prohibitive surgical risk.

Detailed Description

This study is a prospective, multicenter, single-arm, clinical study.

Registry

clinicaltrials.gov

Start Date

October 14, 2022

End Date

May 1, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Genesis Medtech Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with symptomatic aortic valve regurgitation diseases, and New York Heart Association (NYHA) ≥ II;
•Subject must have Society of Thoracic Surgeons (STS) score ≥8% or have been evaluated as inoperable by the surgical team \[defined as rate of death \>50% within 30 d post-surgery or accompanied with irreversible occasions of other factors prevent surgeries (such as heavily calcified (porcelain) ascending aorta, weakness, chest malformation, liver dysfunction, pulmonary dysfunction and so on ); (Note: age of inoperable patients can be expanded to ≥ 50);
•Aortic valve anatomy is suitable for TAVR evaluated by the investigators;
•Patients who can sign informed consent form, and are willing to accept relevant examinations and clinical follow-ups.

Exclusion Criteria

•Active endocarditis;
•Acute myocardial infarction or coronary revascularization occurred within 1 month before procedure;
•Cerebrovascular accident (CVA) occurred within 30 days before procedure;
•The echocardiogram indicates the presence of mass, thrombus or vegetation in left ventricle and left atrium;
•Hypertrophic obstructive cardiomyopathy;
•Other valve diseases that need interventions;
•Previous aortic valve implantation (mechanical or biological);
•Allergic to Nickel-titanium alloys or contrast agents or cattle-originated products;
•Known allergy or contraindication to all anticoagulation, or anticoagulation can not be used during the TAVR;
•In presence one of the following (from selection to the day of procedure index):

Outcomes

Primary Outcomes

Cumulative all-cause mortality

Time Frame: 12 months

All-cause mortality within 12 months of TAVR procedure

Secondary Outcomes

Device success(30 days)
Procedural success(immediate post-surgical)
Evaluation of bioprosthetic valve and cardiac function(30 days, 6 months, 12 months)
Conduction block and malignant arrhythmia(before discharge, 30 days, 6 months, 12 months)
Permanent pacemaker implantation(before discharge, 30 days, 6 months, 12 months)
Functional Improvement of heart ( NYHA）(30 days, 6 months, 12 months)
Quality of life（KCCQ）(30 days, 6 months, 12 months)
Major cardiovascular and cerebrovascular adverse events (MACCE)(before discharge, 30 days, 6 months, 12 months)
Myocardial infarction(before discharge, 30 days, 6 months, 12 months)
Stroke(before discharge, 30 days, 6 months, 12 months)
Major bleeding (life-threatening or crippling)(before discharge, 30 days, 6 months, 12 months)
Acute kidney injury(before discharge, 30 days, 6 months, 12 months)
The incidence of adverse events(12 months)
TAVI related complications(before discharge, 30 days, 6 months, 12 months)
Device defects(intraoperative)
The incidence of serious adverse events(12 months)