INSPIRIS China PMCF Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| EDWARDS INSPIRIS RESILIA Aortic Valve Subjects who were treated with the INSPIRIS RESILIA aortic heart valve. |
Device: EDWARDS INSPIRIS RESILIA Aortic Valve
Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.
|
Outcome Measures
Primary Outcome Measures
- Subject's Occurrence Rate of Study Valve Related Death [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 Structural Valve Deterioration [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 Re-operation on the Study Valve [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 Major Bleeding [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 Thromboembolic Events [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 Stroke [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.
- Subject's Occurrence Rate of Transient Ischemic Attack [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 [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).
Secondary Outcome Measures
- Subject's Average Mean Gradient at 5 Years [5 Years]
Hemodynamic performance - Mean gradients as evaluated by echocardiography
- Subject's Average Peak Gradient at 5 Years [5 Years]
Hemodynamic performance - Peak gradients as evaluated by echocardiography
- Subject's Average Effective Orifice Area at 5 Years [5 Years]
Hemodynamic performance - Effective Orifice Area evaluated by echocardiography
- Subject's Average Effective Orifice Area Index at 5 Years [5 Years]
Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography
- Amount of Aortic Central Regurgitation in Subjects at 5 Years [5 Years]
Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography
- Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years [5 Years]
Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiamen Cardiovascular Hospital Xiamen University | Xiamen | Fujian | China | 361008 |
| 2 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | 450052 |
| 3 | Nanjing First Hospital | Nanjing | Jiangsu | China | 210012 |
| 4 | Fuwai Yunnan Cardiovascular Hospital | Kunming | Yunnan | China | 650102 |
Sponsors and Collaborators
- Edwards Lifesciences
- Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
- Rundo International Pharmaceutical Research & Development Co.,Ltd.
- Fuwai Yunnan Cardiovascular Hospital
Investigators
- Principal Investigator: Hansong Sun, Professor, Fuwai Yunnan Cardiovascular Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-09