A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Disease
- Sponsor
- Jilin Venus Haoyue Medtech Limited
- Enrollment
- 155
- Locations
- 1
- Primary Endpoint
- primary composite safety endpoint
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
Detailed Description
This is a prospective, multicenter, non-randomized interventional study to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve. 155 subjects are estimated to be enrolled in this study. Total enrollment period for this trial is estimated to be 1 year. Follow-up duration is estimated to be 5 years. Overall duration of the trial is estimated to be 6 years. The trial begins with the enrollment of the first subject and ends after the last subject is exited from the trial after completing the last follow-up visit at approximately 5 years, all subjects are fully monitored, all outstanding data queries are resolved.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •Patients who are clinically indicated for aortic valve replacement
- •Patients who are willing and able to participate in the follow-up requirements, and provide written informed consent
Exclusion Criteria
- •Previous surgical or/and transcatheter cardiac valve replacement at any site
- •Previous open-heart surgical valve repair at any site
- •Any percutaneous cardiovascular intervention (excluding diagnostic percutaneous coronary artery intervention), cardiovascular surgery, carotid surgery within 30 days
- •Untreated mitral, tricuspid, or pulmonary valve diseases requiring procedural intervention
- •Untreated clinically significant coronary artery diseases requiring revascularization
- •Acute myocardial infarct within the previous 30 days
- •Severe right heart dysfunction
- •Active infection requiring antibiotic therapy including infective endocarditis
- •Hypertrophic obstructive cardiomyopathy (HOCM)
- •Severe symptomatic carotid artery stenosis
Outcomes
Primary Outcomes
primary composite safety endpoint
Time Frame: 1 year
composite safety endpoint at 1 year, including: valve-related mortality, thromboembolism, aortic valve reintervention, structural valve deterioration, major paravalvular leak (defined as moderate or greater paravalvular leak or any paravalvular leak requiring intervention), valve thrombosis, endocarditis
Secondary Outcomes
- secondary composite safety endpoint(2 through 5 Years)
- Occurrence of each of the following adverse events(baseline, pre-discharge, 30 days, 6 months, 12 months and annually until 5 years thereafter)