Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 255
- Locations
- 13
- Primary Endpoint
- Subject's Occurrence Rate of Study Valve Related Death
Study Overview
Brief Summary
The objective of this post-market trial is to evaluate long term safety and performance of the Edwards Lifesciences INSPIRIS RESILIA aortic valve in Chinese patients in a real-world clinical setting.
Detailed Description
The trial is a multi-center, prospective, single-arm study that will enroll up to 250 subjects. The study is being divided into 2 stages: Stage 1 is enrollment and 5 years of follow-up after implantation. Stage 2 is additional follow-up through 10 years upon authority's feedback if needed.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is 18 years or older
- •Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
- •Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
- •Provide signed informed consent prior to the study participation
Exclusion Criteria
- •Valve implantation is contraindicated per the IFU
- •Requires planned multiple valve replacement/ repair
- •Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
- •Estimated Life expectancy< 12 months
- •Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
Outcomes
Primary Outcomes
Subject's Occurrence Rate of Study Valve Related Death
Time Frame: 5 Years
The primary safety endpoint is the percentage of study valve related death which includes death caused by structural valve deterioration, nonstructural dysfunction, valve thrombosis, embolism, bleeding event, or operated valve endocarditis; death related to reintervention on the operated valve; or sudden, unexplained death.
Subject's Occurrence Rate of Thromboembolic Events
Time Frame: 5 Years
The primary safety endpoint is the rate of thromboembolic events which is an embolic event that occurs in absence of infection (endocarditis) starting from anesthesia time. Embolism may be manifested by a neurologic event (Stroke or Transient Ischemic Attack) or a non-cerebral embolic event.
Subject's Occurrence Rate of Re-operation on the Study Valve
Time Frame: 5 Years
The primary safety endpoint is the reoperation rate on the study valve which is any operation that repairs, alters, or replaces the study valve, which occurs after the completion of the procedure and the transfer out of the procedure room.
Subject's Occurrence Rate of Structural Valve Deterioration
Time Frame: 5 Years
The primary safety endpoint is the percentage of Structural Valve Deterioration which includes dysfunction or deterioration involving the operated valve (exclusive of infection or thrombosis), as determined by re-operation, autopsy, or clinical investigation.
Subject's Occurrence Rate of Major Bleeding
Time Frame: 5 Years
The primary safety endpoint is the rate of major bleeding which is any episode of major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. Vision loss) or necessitates transfusion of 3 or more units of PRBC, pericardiocentesis, or exploration/reoperation for bleeding.
Subject's Occurrence Rate of Transient Ischemic Attack
Time Frame: 5 Years
The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
Time Frame: 5 Years
The primary safety endpoint is the rate of non-cerebral thromboembolism which is an embolus documented operatively, at autopsy, or clinically that produces signs or symptoms attributable to complete or partial obstruction of a peripheral artery (does not include deep vein thrombosis).
Subject's Occurrence Rate of Stroke
Time Frame: 5 Years
The primary safety endpoint is the rate of strokes which is a prolonged (\>72 hours) or permanent neurologic deficit that is usually associated with abnormal results of magnetic resonance imaging or computed tomographic scans.
Secondary Outcomes
- Subject's Average Mean Gradient at 5 Years(5 Years)
- Subject's Average Peak Gradient at 5 Years(5 Years)
- Subject's Average Effective Orifice Area at 5 Years(5 Years)
- Subject's Average Effective Orifice Area Index at 5 Years(5 Years)
- Amount of Aortic Central Regurgitation in Subjects at 5 Years(5 Years)
- Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years(5 Years)