NCT04053088

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
4 countries

22 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Dec 2019Aug 2026

First Submitted

Initial submission to the registry

August 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

6.2 years

First QC Date

August 6, 2019

Last Update Submit

June 11, 2025

Conditions

Cardiovascular Diseases

Keywords

Surgical Aortic Valve Replacement (SAVR)INSPIRIS RESILIADurabilityHemodynamics

Outcome Measures

Primary Outcomes (3)

  • All-cause mortality

    All-cause mortality after 1 year will be investigated

    after 1 year

  • All-cause mortality

    All-cause mortality after 3 years will be investigated

    after 3 years

  • All-cause mortality

    All-cause mortality after 5 years will be investigated

    after 5 years

Secondary Outcomes (3)

  • Mortality

    after 1 year

  • Mortality

    after 3 years

  • Mortality

    after 5 years

Other Outcomes (33)

  • Change in Maximum pressure gradient (Pmax) over time

    after 1 year

  • Change in Maximum pressure gradient (Pmax) over time

    after 3 years

  • Change in Maximum pressure gradient (Pmax) over time

    after 5 years

  • +30 more other outcomes

Study Arms (1)

SAVR patients

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

Device: INSPIRIS RESILIA Aortic Valve™

Interventions

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™

SAVR patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie

Innsbruck, Austria

Location

Kepler Universitätsklinikum Linz

Linz, 4021, Austria

Location

• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie

Salzburg, Austria

Location

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

Wels, Austria

Location

Klinikum Nürnberg

Nuremberg, Bavaria, 90471, Germany

Location

Klinikum Passau/Universität Regensburg

Passau, Bavaria, 94032, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

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

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinik für Herzchirurgie

Oldenburg, Lower Saxony, 26133, Germany

Location

Uniklinik RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Schüchtermann Klinik

Bad Rothenfelde, North Rhine-Westphalia, Germany

Location

Herzzentrum Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

Location

Klinik für Herzchirurgie UKD

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

• Universitätsklinikum Leipzig, Thorax- und Kardiovaskuläre Chirurgie

Leipzig, Saxony, 04103, Germany

Location

BundeswehrKrankenhaus Klinik XVII und XVIII

Koblenz, 56072, Germany

Location

Helios Klinikum Siegburg

Siegburg, 53721, Germany

Location

Universitätsklinikum Ulm

Ulm, 89091, Germany

Location

Helios Klinikum Wuppertal

Wuppertal, 42283, Germany

Location

Catharina Ziekenhuis, Catharina Hart- en Vaatcentrum

Eindhoven, Netherlands

Location

HerzKlinik Hirslanden, Herz- und thorakale Gefässchirurgie

Zurich, Switzerland

Location

HerzZentrum Hirslanden, Herz- und Gefässchirurgie

Zurich, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 29735584BACKGROUND

  • 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.

    PMID: 33766089DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Farhad Bakhtiary, Dr. med.

    Helios Klinik Siegburg

    PRINCIPAL INVESTIGATOR

  • Andreas Zierer, Prof. Dr.

    Kepler University Hosiptal Linz and Hospital Wels-Grieskirchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 12, 2019

Study Start

December 12, 2019

Primary Completion

March 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

DE(15)AU(4)NL(1)CH(2)