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NCT Number: NCT04053088

SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™. The IMPACT Registry will be performed in up to 25 participating sites across Germany, Austria and Switzerland. A minimum number of 500 patients (20 patients per center) will be enrolled. Patients will undergo follow-up visits at baseline, surgery, pre-discharge, year 1, year 3 and year 5.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie, Innsbruck, Austria

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About this study

The INSPIRIS RESILIA Aortic Valve™ is a stented tri-leaflet valve comprised of bovine pericardial tissue. The tissue is created by treating bovine pericardial tissue with Edwards Integrity Preservation. It incorporates a stable capping anticalcification process, which blocks residual aldehyde groups known to bind with calcium. Tissue preservation with glycerol allows the valve to be stored without a traditional liquid-based solution, such as glutaraldehyde. Therefore, valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation.

The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model (Flameng et al., 2015). The RESILIA tissue has been studied in the COMMENCE trial: Two year data show that the NYHA class improved in 65.7% of patients, effective orifice area after implantation was 1.6 ± 0.5 cm2; mean gradient was 10.1 ± 4.3 mmHg; and paravalvular leak was none/trivial in 94.5% of patients (mild to moderate in 0.5%) (Puskas et al., 2017).

On the sizes 19 - 25 mm the INSPIRIS RESILIA Aortic Valve™ has been outfitted with the VFit technology, which incorporates two novel features designed for potential future valve-in-valve procedures: fluoroscopically visible size markers and an expandable cobalt chromium alloy band. No clinical data are available that evaluate the use of the INSPIRIS RESILIA Aortic Valve™ in patients to date.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is at least 18 years old
  • Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™
  • Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years
  • Patient provides written informed consent prior to the procedure and in case of emergency after the procedure.

Exclusion criteria

  • Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial
  • Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
  • Patient has a life expectancy ≤ 12 months for any reason
  • Valve implantation is not possible in accordance with the device IFU
  • Pregnancy

Treatment and study plan

INSPIRIS RESILIA Aortic Valve™

Device

Collection of patient data from patients undergoing Surgical Aortic Valve Replacement (SAVR) by usage of the INSPIRIS RESILIA aortic valve™

Primary outcomes

  1. All-cause mortality

    Time frame: after 1 year

    All-cause mortality after 1 year will be investigated

  2. All-cause mortality

    Time frame: after 3 years

    All-cause mortality after 3 years will be investigated

  3. All-cause mortality

    Time frame: after 5 years

    All-cause mortality after 5 years will be investigated

Secondary outcomes

  1. Mortality

    Time frame: after 1 year

    All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation

  2. Mortality

    Time frame: after 3 years

    All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation

  3. Mortality

    Time frame: after 5 years

    All cause, cardiac and valve-related mortality in the overall study population and in different patient subgroups at all timepoints: Chronic kidney disease, diabetes, hypertension, metabolic syndrome, inflammation

Other outcomes

  1. Change in Maximum pressure gradient (Pmax) over time

    Time frame: after 1 year

    Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

  2. Change in Maximum pressure gradient (Pmax) over time

    Time frame: after 3 years

    Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

  3. Change in Maximum pressure gradient (Pmax) over time

    Time frame: after 5 years

    Change in Pmax in mmHg as an indicator of patient prosthesis mismatch

  4. Change in mean pressure gradient (Pmean) over time

    Time frame: after 1 year

    Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

  5. Change in mean pressure gradient (Pmean) over time

    Time frame: after 3 years

    Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

  6. Change in mean pressure gradient (Pmean) over time

    Time frame: after 5 years

    Change in Pmean in mmHg as an indicator of patient prosthesis mismatch

  7. Change in velocity time integral (VTI) over time

    Time frame: after 1 year

    Change in VTI as an indicator of patient prosthesis mismatch

  8. Change in velocity time integral (VTI) over time

    Time frame: after 3 years

    Change in VTI as an indicator of patient prosthesis mismatch

  9. Change in velocity time integral (VTI) over time

    Time frame: after 5 years

    Change in VTI as an indicator of patient prosthesis mismatch

  10. Change in prostesis opening area (EOA) over time

    Time frame: after 1 year

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

  11. Change in prostesis opening area (EOA) over time

    Time frame: after 3 years

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

  12. Change in prostesis opening area (EOA) over time

    Time frame: after 5 years

    Change in EOA in mm2 as an indicator of patient prosthesis mismatch

  13. Change in left ventricular ejection fraction (LVEF) over time

    Time frame: after 1 year

    Change in LVEF in % as an indicator of patient prosthesis mismatch

  14. Change in left ventricular ejection fraction (LVEF) over time

    Time frame: after 3 years

    Change in LVEF in % as an indicator of patient prosthesis mismatch

  15. Change in left ventricular ejection fraction (LVEF) over time

    Time frame: after 5 years

    Change in LVEF in % as an indicator of patient prosthesis mismatch

  16. Occurence of paravalvular leaks

    Time frame: after 1 year

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

  17. Occurence of paravalvular leaks

    Time frame: after 3 years

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

  18. Occurence of paravalvular leaks

    Time frame: after 5 years

    Occurence of paravalvular leaks as an indicator of patient prostheis mismatch

  19. Occurence of structural valve detioration (SVD) over time

    Time frame: after 1 year

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

  20. Occurence of structural valve detioration (SVD) over time

    Time frame: after 3 years

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

  21. Occurence of structural valve detioration (SVD) over time

    Time frame: after 5 years

    SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018

  22. Occurence of repeat procedures (valve-in-valve reoperation)

    Time frame: after 1 year

    Any repeat procedures will be documented and assessed

  23. Occurence of repeat procedures (valve-in-valve reoperation)

    Time frame: after 3 years

    Any repeat procedures will be documented and assessed

  24. Occurence of repeat procedures (valve-in-valve reoperation)

    Time frame: after 5 years

    Any repeat procedures will be documented and assessed

  25. New York Heart Association (NYHA) functional class compared to baseline

    Time frame: after 1 year

    NYHA class will be determined at follow-up visits

  26. New York Heart Association (NYHA) functional class compared to baseline

    Time frame: after 3 years

    NYHA class will be determined at follow-up visits

  27. New York Heart Association (NYHA) functional class compared to baseline

    Time frame: after 5 years

    NYHA class will be determined at follow-up visits

  28. Freedom from valve-related rehospitalization

    Time frame: after 1 year

    any valve related hospitalizations will be documented and assessed

  29. Freedom from valve-related rehospitalization

    Time frame: after 3 years

    any valve related hospitalizations will be documented and assessed

  30. Freedom from valve-related rehospitalization

    Time frame: after 5 years

    any valve related hospitalizations will be documented and assessed

  31. Need for new pacemaker implant

    Time frame: after 1 year

    Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at baseline) will be documented and assessed

  32. Need for new pacemaker implant

    Time frame: after 3 years

    Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at the preceding follow-up visit) will be documented and assessed

  33. Need for new pacemaker implant

    Time frame: after 5 years

    Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at the preceding follow-up visit) will be documented and assessed

Sponsors and collaborators

Lead sponsor

Institut für Pharmakologie und Präventive Medizin

Network

Collaborators

  • Edwards Lifesciences

Registry information

Official study title

Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.

Acronym: IMPACT

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Aug 12, 2019
Registry last updated
Jul 30, 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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