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 :
Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : December 21, 2021
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Condition or disease | Intervention/treatment |
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Cardiovascular Diseases | Device: INSPIRIS RESILIA Aortic Valve™ |
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 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 |
Group/Cohort | Intervention/treatment |
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SAVR patients
patients undergoing surgical aortic valve replacement (SAVR) by usage of the INSPIRIS RESILIA Aortic valve™
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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™ |
- All-cause mortality [ Time Frame: after 1 year ]All-cause mortality after 1 year will be investigated
- All-cause mortality [ Time Frame: after 3 years ]All-cause mortality after 3 years will be investigated
- All-cause mortality [ Time Frame: after 5 years ]All-cause mortality after 5 years will be investigated
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Change in velocity time integral (VTI) over time [ Time Frame: after 1 year ]Change in VTI as an indicator of patient prosthesis mismatch
- Change in velocity time integral (VTI) over time [ Time Frame: after 3 years ]Change in VTI as an indicator of patient prosthesis mismatch
- Change in velocity time integral (VTI) over time [ Time Frame: after 5 years ]Change in VTI as an indicator of patient prosthesis mismatch
- 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
- 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
- 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
- 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
- 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
- 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
- Occurence of paravalvular leaks [ Time Frame: after 1 year ]Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
- Occurence of paravalvular leaks [ Time Frame: after 3 years ]Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
- Occurence of paravalvular leaks [ Time Frame: after 5 years ]Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
- 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
- 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
- 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
- Occurence of repeat procedures (valve-in-valve reoperation) [ Time Frame: after 1 year ]Any repeat procedures will be documented and assessed
- Occurence of repeat procedures (valve-in-valve reoperation) [ Time Frame: after 3 years ]Any repeat procedures will be documented and assessed
- Occurence of repeat procedures (valve-in-valve reoperation) [ Time Frame: after 5 years ]Any repeat procedures will be documented and assessed
- New York Heart Association (NYHA) functional class compared to baseline [ Time Frame: after 1 year ]NYHA class will be determined at follow-up visits
- New York Heart Association (NYHA) functional class compared to baseline [ Time Frame: after 3 years ]NYHA class will be determined at follow-up visits
- New York Heart Association (NYHA) functional class compared to baseline [ Time Frame: after 5 years ]NYHA class will be determined at follow-up visits
- Freedom from valve-related rehospitalization [ Time Frame: after 1 year ]any valve related hospitalizations will be documented and assessed
- Freedom from valve-related rehospitalization [ Time Frame: after 3 years ]any valve related hospitalizations will be documented and assessed
- Freedom from valve-related rehospitalization [ Time Frame: after 5 years ]any valve related hospitalizations will be documented and assessed
- 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
- 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
- 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

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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 |
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.
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

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

Principal Investigator: | Farhad Bakhtiary, Dr. med. | Helios Klinik Siegburg | |
Principal Investigator: | Andreas Zierer, Prof. Dr. | Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: | December 21, 2021 |
Last Verified: | December 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Surgical Aortic Valve Replacement (SAVR) INSPIRIS RESILIA Durability Hemodynamics |
Cardiovascular Diseases |