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

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ClinicalTrials.gov Identifier: NCT04053088
Recruitment Status : Recruiting
First Posted : August 12, 2019
Last Update Posted : February 7, 2020
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

Study Description
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Brief Summary:
The INSPIRIS 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 INSPIRIS 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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Device: INSPIRIS RESILIA Aortic Valve™

Detailed Description:

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Surgical Aortic Valve Replacement: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Actual Study Start Date : December 12, 2019
Estimated Primary Completion Date : March 1, 2026
Estimated Study Completion Date : August 1, 2026
Groups and Cohorts
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Group/Cohort Intervention/treatment
SAVR patients
patients undergoing surgical aortic valve replacement (SAVR) by usage of the INSPIRIS RESILIA Aortic valve™
 Device: INSPIRIS RESILIA Aortic Valve™
Collection of patient data from patients undergoing Surgical Aortic Valve Replacement (SAVR) by usage of the INSPIRIS RESILIA aortic valve™


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Minimum of 500 patients (20 patients per center) undergoing Surgical Aortic Valve Replacement (SAVR) using the INSPIRIS RESILIA aortic valve™ (all comers).

The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from the COMMENCE Trial dataset (Puskas et al., 2017) that all-cause mortality is around 1.2% at year 1 and 2.0% at year 2.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04053088


Contacts
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Contact: Beate Botta, PhD +4944718503325 beate.botta@ippmed.de
Contact: Claudia Lueske, PhD +4944718503324 claudia.lueske@ippmed.de

Locations
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Austria
Kepler Universitätsklinikum Linz Recruiting
Linz, Austria, 4021
Contact: Andreas Zierer, Prof.         
Germany
Herzzentrum Bergmannsheil Not yet recruiting
Bochum, Germany, 44789
Contact: Justus Strauch, Prof.       justus.strauch@bergmannsheil.de   
Helios Klinikum Siegburg Recruiting
Siegburg, Germany, 53721
Contact: Farhad Bakhtiary, Prof. Dr.       farhad.bakhtiary@helios-gesundheit.de   
Helios Klinikum Wuppertal Recruiting
Wuppertal, Germany, 42283
Contact: Farhad Bakhtiary, Prof. Dr.       farhad.bakhtiary@helios-gesundheit.de   
Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Edwards Lifesciences
Investigators
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Principal Investigator: Farhad Bakhtiary, Dr. med. Helios Klinik Siegburg
Principal Investigator: Andreas Zierer, Prof. Dr. Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen
More Information
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Publications:

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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT04053088    
Other Study ID Numbers: IPPM2019IMPACT
First Posted: August 12, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Pharmakologie und Präventive Medizin:
Surgical Aortic Valve Replacement (SAVR)
INSPIRIS RESILIA
Durability
Hemodynamics
Additional relevant MeSH terms:
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Cardiovascular Diseases