INSPIRIS China PMCF Study

Active, not recruiting

• Conditions: Aortic Valve Replacement

• Registration Number: NCT05404880
• Lead Sponsor: Edwards Lifesciences

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 Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-03
• Study Start: 2022-07-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

1. Subject is 18 years or older
2. Subjects requiring an elective replacement of their native or prosthetic aortic valve as indicated per the IFU
3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, with or without ascending aorta replacement
4. Provide signed informed consent prior to the study participation

Exclusion Criteria

1. Valve implantation is contraindicated per the IFU
2. Requires planned multiple valve replacement/ repair
3. Has active endocarditis/myocarditis prior to the scheduled aortic replacement surgery
4. Estimated Life expectancy< 12 months
5. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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 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 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 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).
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 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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Fuwai Hospital, CAMS & PUMC; 🇨🇳 Beijing, Beijing, 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

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