An observational study in Cardiovascular Diseases, sponsored by Institut für Pharmakologie und Präventive Medizin. Active, not recruiting at 22 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 500 is close to the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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™
All-cause mortality
All-cause mortality after 1 year will be investigated
Time frame: after 1 year
All-cause mortality
All-cause mortality after 3 years will be investigated
Time frame: after 3 years
All-cause mortality
All-cause mortality after 5 years will be investigated
Time frame: after 5 years
Mortality
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
Time frame: after 1 year
Mortality
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
Time frame: after 3 years
Mortality
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
Time frame: after 5 years
Change in Maximum pressure gradient (Pmax) over time
Change in Pmax in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 1 year
Change in Maximum pressure gradient (Pmax) over time
Change in Pmax in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 3 years
Change in Maximum pressure gradient (Pmax) over time
Change in Pmax in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 5 years
Change in mean pressure gradient (Pmean) over time
Change in Pmean in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 1 year
Change in mean pressure gradient (Pmean) over time
Change in Pmean in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 3 years
Change in mean pressure gradient (Pmean) over time
Change in Pmean in mmHg as an indicator of patient prosthesis mismatch
Time frame: after 5 years
Change in velocity time integral (VTI) over time
Change in VTI as an indicator of patient prosthesis mismatch
Time frame: after 1 year
Change in velocity time integral (VTI) over time
Change in VTI as an indicator of patient prosthesis mismatch
Time frame: after 3 years
Change in velocity time integral (VTI) over time
Change in VTI as an indicator of patient prosthesis mismatch
Time frame: after 5 years
Change in prostesis opening area (EOA) over time
Change in EOA in mm2 as an indicator of patient prosthesis mismatch
Time frame: after 1 year
Change in prostesis opening area (EOA) over time
Change in EOA in mm2 as an indicator of patient prosthesis mismatch
Time frame: after 3 years
Change in prostesis opening area (EOA) over time
Change in EOA in mm2 as an indicator of patient prosthesis mismatch
Time frame: after 5 years
Change in left ventricular ejection fraction (LVEF) over time
Change in LVEF in % as an indicator of patient prosthesis mismatch
Time frame: after 1 year
Change in left ventricular ejection fraction (LVEF) over time
Change in LVEF in % as an indicator of patient prosthesis mismatch
Time frame: after 3 years
Change in left ventricular ejection fraction (LVEF) over time
Change in LVEF in % as an indicator of patient prosthesis mismatch
Time frame: after 5 years
Occurence of paravalvular leaks
Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
Time frame: after 1 year
Occurence of paravalvular leaks
Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
Time frame: after 3 years
Occurence of paravalvular leaks
Occurence of paravalvular leaks as an indicator of patient prostheis mismatch
Time frame: after 5 years
Occurence of structural valve detioration (SVD) over time
SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018
Time frame: after 1 year
Occurence of structural valve detioration (SVD) over time
SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018
Time frame: after 3 years
Occurence of structural valve detioration (SVD) over time
SVD to be determined by imaging methods (e.g. Echocardiography) following Salaun et al. 2018
Time frame: after 5 years
Occurence of repeat procedures (valve-in-valve reoperation)
Any repeat procedures will be documented and assessed
Time frame: after 1 year
Occurence of repeat procedures (valve-in-valve reoperation)
Any repeat procedures will be documented and assessed
Time frame: after 3 years
Occurence of repeat procedures (valve-in-valve reoperation)
Any repeat procedures will be documented and assessed
Time frame: after 5 years
New York Heart Association (NYHA) functional class compared to baseline
NYHA class will be determined at follow-up visits
Time frame: after 1 year
New York Heart Association (NYHA) functional class compared to baseline
NYHA class will be determined at follow-up visits
Time frame: after 3 years
New York Heart Association (NYHA) functional class compared to baseline
NYHA class will be determined at follow-up visits
Time frame: after 5 years
Freedom from valve-related rehospitalization
any valve related hospitalizations will be documented and assessed
Time frame: after 1 year
Freedom from valve-related rehospitalization
any valve related hospitalizations will be documented and assessed
Time frame: after 3 years
Freedom from valve-related rehospitalization
any valve related hospitalizations will be documented and assessed
Time frame: after 5 years
Need for new pacemaker implant
Any occurence of new pacemaker implant (e. g. when the participant did not have a pacemaker at baseline) will be documented and assessed
Time frame: after 1 year
Need for new pacemaker implant
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
Time frame: after 3 years
Need for new pacemaker implant
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
Time frame: after 5 years
Started Dec 2019 (actual). Primary completion is estimated for Oct 2026, 81 months after the start.
Of 580 non-industry observational studies under Cardiovascular Diseases, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 196. This study's planned 81 months is above that.
Counting every sponsor, half of 664 studies reached it within 61 months; a quarter within 24 and three quarters within 192.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Institut für Pharmakologie und Präventive Medizin