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NCT Number: NCT05404880

INSPIRIS China PMCF Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards INSPIRIS RESILIA Aortic Valve

Device

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

Primary outcomes

  1. Subject's Occurrence Rate of Study Valve Related Death

    Time frame: 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.

  2. Subject's Occurrence Rate of Structural Valve Deterioration

    Time frame: 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.

  3. Subject's Occurrence Rate of Re-operation on the Study Valve

    Time frame: 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.

  4. Subject's Occurrence Rate of Major Bleeding

    Time frame: 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.

  5. Subject's Occurrence Rate of Thromboembolic Events

    Time frame: 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.

  6. Subject's Occurrence Rate of Stroke

    Time frame: 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.

  7. Subject's Occurrence Rate of Transient Ischemic Attack

    Time frame: 5 Years

    The primary safety endpoint is the rate of transient ischemic attacks which is characterized by fully reversible symptoms of short duration.

  8. Subject's Occurrence Rate of Non-Cerebral Thromboembolism

    Time frame: 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 outcomes

  1. Subject's Average Mean Gradient at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Mean gradients as evaluated by echocardiography

  2. Subject's Average Peak Gradient at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Peak gradients as evaluated by echocardiography

  3. Subject's Average Effective Orifice Area at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Effective Orifice Area evaluated by echocardiography

  4. Subject's Average Effective Orifice Area Index at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography

  5. Amount of Aortic Central Regurgitation in Subjects at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Aortic central regurgitation evaluated by echocardiography

  6. Amount of Aortic Paravalvular Regurgitation in Subjects at 5 Years

    Time frame: 5 Years

    Hemodynamic performance - Aortic paravalvular regurgitation evaluated by echocardiography

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: INSPIRIS China

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Jun 3, 2022
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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