INSPIRIS China PMCF Study (INSPIRIS China)

Post-Market Clinical Follow-up Study of Edwards Lifesciences INSPIRIS RESILIA Aortic Valve in Chinese Population

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Replacement
• Intervention / Treatment: Device: EDWARDS INSPIRIS RESILIA Aortic Valve

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 Type: Observational
• Enrollment (Actual): 255

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230002
      • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Beijing AnZhen Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100037
      • FuWai Hospital, CAMS & PUMC
  • Fujian
    • Xiamen, Fujian, China, 361008
      • Xiamen Cardiovascular Hospital Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518038
      • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen
  • Henan
    • Zhengzhou, Henan, China, 450052
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China, 450008
      • Henan Provincial Chest Hospital
    • Zhengzhou, Henan, China, 451460
      • Fuwai Central China Cardiovascular Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210012
      • Nanjing First Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710065
      • The First Affiliated Hospital Of Xi'an Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
  • Yunnan
    • Kunming, Yunnan, China, 650102
      • Fuwai Yunnan Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Average Mean Gradient at 5 Years	Hemodynamic performance - Mean gradients as evaluated by echocardiography	5 Years
Subject's Average Peak Gradient at 5 Years	Hemodynamic performance - Peak gradients as evaluated by echocardiography	5 Years
Subject's Average Effective Orifice Area at 5 Years	Hemodynamic performance - Effective Orifice Area evaluated by echocardiography	5 Years
Subject's Average Effective Orifice Area Index at 5 Years	Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography	5 Years
Amount of Aortic Central Regurgitation in Subjects at 5 Years	Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography	5 Years
Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years	Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography	5 Years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital; Rundo International Pharmaceutical Research & Development Co.,Ltd.; Edwards (Shanghai) Lifesciences Medical Supplies Co., Ltd.
• Investigators: Principal Investigator: Hansong Sun, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2021-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes