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Cardiovascular DiseasesIMPACTNCT04053088

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

An observational study of Cardiovascular Diseases, run by Institut für Pharmakologie und Präventive Medizin at 22 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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™. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
INSPIRIS RESILIA Aortic Valve™
Type of treatment
Medical device
How many people
500 participants
Where
22 sitesin 4 countries
Study dates
12 Dec 2019to 1 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

22 sites in 4 countries.

22 sites in 4 countries

Germany15 sites

  • Uniklinik RWTH Aachen

    Aachen, North Rhine-Westphalia, 52074

  • Schüchtermann Klinik

    Bad Rothenfelde, North Rhine-Westphalia

  • Herzzentrum Bergmannsheil

    Bochum, North Rhine-Westphalia, 44789

  • Klinik für Herzchirurgie UKD

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsklinikum Essen

    Essen, North Rhine-Westphalia, 45147

  • • Universitätsklinikum Frankfurt, Thorax-, Herz- und thorakale Gefässchirurgie

    Frankfurt am Main, Hesse, 60590

  • BundeswehrKrankenhaus Klinik XVII und XVIII

    Koblenz, 56072

  • • Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie

    Leipzig, Saxony, 04103

  • Klinikum Nürnberg

    Nuremberg, Bavaria, 90471

  • Universitätsklinik für Herzchirurgie

    Oldenburg, Lower Saxony, 26133

  • Klinikum Passau/Universität Regensburg

    Passau, Bavaria, 94032

  • Helios Klinikum Siegburg

    Siegburg, 53721

  • Universitätsklinikum Ulm

    Ulm, 89091

  • Helios Klinikum Wuppertal

    Wuppertal, 42283

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Austria4 sites

  • Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie

    Innsbruck

  • Kepler Universitätsklinikum Linz

    Linz, 4021

  • • Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie

    Salzburg

  • • Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie

    Wels

Other trials in Austria

Switzerland2 sites

  • HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie

    Zurich

  • HerzZentrum Hirslanden, Herz- und Gefässchirurgie

    Zurich

Other trials in Switzerland

Netherlands1 site

  • Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum

    Eindhoven

Other trials in Netherlands

About this study

Official title: Surgical Aortic Valve Replacement: 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.

Read the 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.

Being tested
INSPIRIS RESILIA Aortic Valve™
Keywords
Surgical Aortic Valve Replacement (SAVR), INSPIRIS RESILIA, Durability, Hemodynamics
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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™

Study groups in NCT04053088
Study groupRoleWhat they receive
SAVR patientspatients undergoing surgical aortic valve replacement (SAVR) by usage of the INSPIRIS RESILIA Aortic valve™
Receives: Device: INSPIRIS RESILIA Aortic Valve™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    All-cause mortality after 1 year will be investigated

    Measured: after 1 year

  2. All-cause mortality

    All-cause mortality after 3 years will be investigated

    Measured: after 3 years

  3. All-cause mortality

    All-cause mortality after 5 years will be investigated

    Measured: after 5 years

Secondary outcomes (3)

  1. 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

    Measured: after 1 year

  2. 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

    Measured: after 3 years

  3. 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

    Measured: after 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2019
  2. Study start12 Dec 2019
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04053088
Sponsor's protocol ID
IPPM2019IMPACT
Acronym
IMPACT
Status last verified
Jul 2026
First submitted
6 Aug 2019
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Salaun E, Clavel MA, Rodes-Cabau J, Pibarot P. Bioprosthetic aortic valve durability in the era of transcatheter aortic valve implantation. Heart. 2018 Aug;104(16):1323-1332. doi: 10.1136/heartjnl-2017-311582. Epub 2018 May 7.

    PubMed 29735584

  • Bakhtiary F, Benedikt P, Bonaros N, Borger M, Doss M, Feyrer R, Grunenfelder J, Owais T, Karimli S, Lam KY, Liebold A, Martens A, Massoudy P, Batashev I, Poling J, Scherner MP, Strauch J, Thielmann M, Votsch A, Walther T, Weber A, Wiesinger S, Eden M, Kammler J, Botta B, Trushina N, Vijayan A, Bramlage P, Zierer A. Three-Year Outcomes After Surgical Aortic Valve Replacement With a Bioprosthetic Valve from the Multi-Centre IMPACT Registry. Interdiscip Cardiovasc Thorac Surg. 2026 Mar 12;41(3):ivag056. doi: 10.1093/icvts/ivag056.

    PubMed 41787958

  • Bakhtiary F, Ahmad AE, Autschbach R, Benedikt P, Bonaros N, Borger M, Dewald O, Feyrer R, Geissler HJ, Grunenfelder J, Lam KY, Leyh R, Liebold A, Czesla M, Mehdiani A, Pollari F, Salamate S, Strauch J, Votsch A, Weber A, Wendt D, Botta B, Bramlage P, Zierer A. Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry. J Cardiothorac Surg. 2021 Mar 25;16(1):51. doi: 10.1186/s13019-021-01434-w.

    PubMed 33766089

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Institut für Pharmakologie und Präventive Medizin at 22 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Germany, Austria, Switzerland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: after 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04053088, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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