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

NCT ID: NCT04053088

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-12
• Study Completion Date: 2026-08-01

Brief 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™. 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.

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.

Conditions

Cardiovascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SAVR patients

patients undergoing surgical aortic valve replacement (SAVR) by usage of the INSPIRIS RESILIA Aortic valve™

INSPIRIS RESILIA Aortic Valve™

Intervention Type: DEVICE

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

Interventions

INSPIRIS RESILIA Aortic Valve™

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: collaborator

Institut für Pharmakologie und Präventive Medizin

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farhad Bakhtiary, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Helios Klinik Siegburg

Andreas Zierer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen

Locations

Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie

Innsbruck, , Austria

Kepler Universitätsklinikum Linz

Linz, , Austria

• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie

Salzburg, , Austria

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

Wels, , Austria

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

Klinikum Passau/Universität Regensburg

Passau, Bavaria, Germany

Universitätsklinikum Würzburg

Würzburg, Bavaria, Germany

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

Frankfurt am Main, Hesse, Germany

Universitätsklinik für Herzchirurgie

Oldenburg, Lower Saxony, Germany

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Schüchtermann Klinik

Bad Rothenfelde, North Rhine-Westphalia, Germany

Herzzentrum Bergmannsheil

Bochum, North Rhine-Westphalia, Germany

Klinik für Herzchirurgie UKD

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

• Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie

Leipzig, Saxony, Germany

BundeswehrKrankenhaus Klinik XVII und XVIII

Koblenz, , Germany

Helios Klinikum Siegburg

Siegburg, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Helios Klinikum Wuppertal

Wuppertal, , Germany

Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum

Eindhoven, , Netherlands

HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie

Zurich, , Switzerland

HerzZentrum Hirslanden, Herz- und Gefässchirurgie

Zurich, , Switzerland

Countries

Austria; Germany; Netherlands; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 29735584 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33766089 (View on PubMed)

Other Identifiers

IPPM2019IMPACT

Identifier Type: -

Identifier Source: org_study_id