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.
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 Type
OBSERVATIONAL
Enrollment
255
Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Subject's Occurrence Rate of Study Valve Related Death
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.
Time frame: 5 Years
Subject's Occurrence Rate of Structural Valve Deterioration
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.
Time frame: 5 Years
Subject's Occurrence Rate of Re-operation on the Study Valve
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.
Time frame: 5 Years
Subject's Occurrence Rate of Major Bleeding
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.
Time frame: 5 Years
Subject's Occurrence Rate of Thromboembolic Events
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.
Time frame: 5 Years
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Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, China
Henan Provincial Chest Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Nanjing First Hospital
Nanjing, Jiangsu, China
...and 3 more locations
Subject's Occurrence Rate of Stroke
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.
Time frame: 5 Years
Subject's Occurrence Rate of Transient Ischemic Attack
The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.
Time frame: 5 Years
Subject's Occurrence Rate of Non-Cerebral Thromboembolism
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).
Time frame: 5 Years
Subject's Average Mean Gradient at 5 Years
Hemodynamic performance - Mean gradients as evaluated by echocardiography
Time frame: 5 Years
Subject's Average Peak Gradient at 5 Years
Hemodynamic performance - Peak gradients as evaluated by echocardiography
Time frame: 5 Years
Subject's Average Effective Orifice Area at 5 Years
Hemodynamic performance - Effective Orifice Area evaluated by echocardiography
Time frame: 5 Years
Subject's Average Effective Orifice Area Index at 5 Years
Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography
Time frame: 5 Years
Amount of Aortic Central Regurgitation in Subjects at 5 Years
Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography
Time frame: 5 Years
Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years
Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography
Time frame: 5 Years