INSPIRIS China PMCF Study

NCT05404880 | Active Not Recruiting FDA Device

• 1 other identifier: 2021-09
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 13

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.

Conditions

Aortic Valve Replacement

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  5 Years

• 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.

  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.

  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).

  5 Years

Secondary Outcomes (6)

• 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

Study Arms (1)

EDWARDS INSPIRIS RESILIA Aortic Valve

Subjects who were treated with the INSPIRIS RESILIA aortic heart valve.

Device: EDWARDS INSPIRIS RESILIA Aortic Valve

Interventions

EDWARDS INSPIRIS RESILIA Aortic Valve DEVICE

Surgical replacement of the aortic valve with the INSPIRIS RESILIA Aortic Valve.

EDWARDS INSPIRIS RESILIA Aortic Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects requiring an elective replacement of their native or prosthetic aortic valve who have agreed to participate in the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead
• Rundo International Pharmaceutical Research & Development Co.,Ltd.: collaborator
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator
• Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.: collaborator

Study Sites (13)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, 230002, China

Location

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, 100037, China

Location

Xiamen Cardiovascular Hospital Xiamen University

Xiamen, Fujian, 361008, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, 518038, China

Location

Henan Provincial Chest Hospital

Zhengzhou, Henan, 450008, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, 451460, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710065, China

Location

Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Fuwai Yunnan Cardiovascular Hospital

Kunming, Yunnan, 650102, China

Location

Study Officials

• Hansong Sun, Professor

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 3, 2022
• Study Start: July 13, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)