Inspiris Resilia Durability Registry

NCT03666741 | Active Not Recruiting DMC

• 1 other identifier: HVT-R18-IND
• Study Type: observational
• Target: 400
• Locations: 9 countries
• Sites: 21

Brief Summary

Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.

Conditions

Aortic Valve Stenosis

Keywords

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Surgical valve

Outcome Measures

Primary Outcomes (2)

• Time-related valve safety

  Composite endpoint according to VARC-2 depicted as freedom from event: * SVD (structural valve deterioration) * Valve-related dysfunction * Requirement of repeat procedure * Prosthetic valve endocarditis * Prosthetic valve thrombosis * Thromboembolic events (e.g. stroke) * Valve-related VARC bleeding

  Year 1

• Freedom from severe SVD (structural valve deterioration)

  Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography

  Year 5

Interventions

AVR with or without CABG DEVICE

Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients under the age of 60 with an indication for surgical AVR who will receive an Edwards INSPIRIS RESILIA aortic valve prosthesis.

You may qualify if:

• Age 18 to 60 years inclusive
• Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
• Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
• Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
• Subject provides written informed consent prior to the procedure

You may not qualify if:

• Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
• Previous aortic valve replacement
• Valve implantation is not possible in accordance with the device IFU
• Subject has a life expectancy ≤ 12 months for any reason
• \. Valve implantation is not possible in accordance with the device IFU

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Edwards Lifesciences: collaborator

Study Sites (21)

University Clinics St. Pölten

Sankt Pölten, 3100, Austria

Location

Heart Center Hietzing

Vienna, 1080, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

KU Leuven

Leuven, Belgium

Location

Institut de Cardiologie de Montréal, Université de Montréal

Montreal, H1T 1C8, Canada

Location

Laval University

Québec, G1v 0A6, Canada

Location

Hopital de la Timone

Marseille, 13005, France

Location

L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)

Nantes, 44100, France

Location

Centre Hospitalier Universitaire (CHU) de Rennes

Rennes, 35033, France

Location

CHRU - Hospital Trousseau

Tours, France

Location

UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Heart Center Leipzig

Leipzig, Germany

Location

University Hospital Careggi

Florence, 50139, Italy

Location

Centro Cardiologico Monzino

Milan, 20138, Italy

Location

European Hospital Rome

Roma, Italy

Location

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

Location

Erasmus Medisch Centrum

Rotterdam, 3015 CE, Netherlands

Location

University Hospital Virgen de la Arrixaca

Murcia, 30120, Spain

Location

NHS Lothian

Edinburgh, EH1 3EG, United Kingdom

Location

Glenfield Hospital

Glenfield, LE3 9QP, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (8)

• Flameng W, Hermans H, Verbeken E, Meuris B. A randomized assessment of an advanced tissue preservation technology in the juvenile sheep model. J Thorac Cardiovasc Surg. 2015 Jan;149(1):340-5. doi: 10.1016/j.jtcvs.2014.09.062. Epub 2014 Sep 28.

  PMID: 25439467 BACKGROUND

• Puskas JD, Bavaria JE, Svensson LG, Blackstone EH, Griffith B, Gammie JS, Heimansohn DA, Sadowski J, Bartus K, Johnston DR, Rozanski J, Rosengart T, Girardi LN, Klodell CT, Mumtaz MA, Takayama H, Halkos M, Starnes V, Boateng P, Timek TA, Ryan W, Omer S, Smith CR; COMMENCE Trial Investigators. The COMMENCE trial: 2-year outcomes with an aortic bioprosthesis with RESILIA tissue. Eur J Cardiothorac Surg. 2017 Sep 1;52(3):432-439. doi: 10.1093/ejcts/ezx158.

  PMID: 28605428 BACKGROUND

• Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. EuroIntervention. 2012 Nov 22;8(7):782-95. doi: 10.4244/EIJV8I7A121.

  PMID: 23022744 BACKGROUND

• Dvir D, Bourguignon T, Otto CM, Hahn RT, Rosenhek R, Webb JG, Treede H, Sarano ME, Feldman T, Wijeysundera HC, Topilsky Y, Aupart M, Reardon MJ, Mackensen GB, Szeto WY, Kornowski R, Gammie JS, Yoganathan AP, Arbel Y, Borger MA, Simonato M, Reisman M, Makkar RR, Abizaid A, McCabe JM, Dahle G, Aldea GS, Leipsic J, Pibarot P, Moat NE, Mack MJ, Kappetein AP, Leon MB; VIVID (Valve in Valve International Data) Investigators. Standardized Definition of Structural Valve Degeneration for Surgical and Transcatheter Bioprosthetic Aortic Valves. Circulation. 2018 Jan 23;137(4):388-399. doi: 10.1161/CIRCULATIONAHA.117.030729.

  PMID: 29358344 BACKGROUND

• Capodanno D, Petronio AS, Prendergast B, Eltchaninoff H, Vahanian A, Modine T, Lancellotti P, Sondergaard L, Ludman PF, Tamburino C, Piazza N, Hancock J, Mehilli J, Byrne RA, Baumbach A, Kappetein AP, Windecker S, Bax J, Haude M. Standardized definitions of structural deterioration and valve failure in assessing long-term durability of transcatheter and surgical aortic bioprosthetic valves: a consensus statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI) endorsed by the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur J Cardiothorac Surg. 2017 Sep 1;52(3):408-417. doi: 10.1093/ejcts/ezx244. No abstract available.

  PMID: 28874031 BACKGROUND

• De Paulis R, Bakhtiary F, Ahmad AE, Andreas M, Autschbach R, Benedikt P, Binder K, Bonaros N, Borger M, Bourguignon T, Canovas S, Coscioni E, Dagenais F, Demers P, Dewald O, Doll N, Feyrer R, Geissler HJ, Grabenwoger M, Grunenfelder J, Kueri S, Lam KY, Langanay T, Laufer G, Van Leeuwen W, Karimli S, Liebold A, Mariscalco G, Massoudy P, Mehdiani A, Pessotto R, Pollari F, Poling J, Polvani G, Ricci A, Roussel JC, Salamate S, Siepe M, Stefano P, Strauch J, Theron A, Votsch A, Weber A, Wendler O, Thielmann M, Eden M, Botta B, Bramlage P, Meuris B, Zierer A. Gender-based outcomes following surgical aortic valve replacement: a multicentre propensity score matching analysisdagger. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf099. doi: 10.1093/ejcts/ezaf099.

  PMID: 40608978 DERIVED

• Meuris B, Roussel JC, Borger MA, Siepe M, Stefano P, Laufer G, Langanay T, Theron A, Grabenwoger M, Binder K, Demers P, Pessotto R, van Leeuwen W, Bourguignon T, Canovas S, Mariscalco G, Coscioni E, Dagenais F, Wendler O, Polvani G, Eden M, Botta B, Bramlage P, De Paulis R. Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry. Interdiscip Cardiovasc Thorac Surg. 2023 Oct 4;37(4):ivad115. doi: 10.1093/icvts/ivad115.

  PMID: 37462612 DERIVED

• Meuris B, Borger MA, Bourguignon T, Siepe M, Grabenwoger M, Laufer G, Binder K, Polvani G, Stefano P, Coscioni E, van Leeuwen W, Demers P, Dagenais F, Canovas S, Theron A, Langanay T, Roussel JC, Wendler O, Mariscalco G, Pessotto R, Botta B, Bramlage P, de Paulis R. Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020 May 27;15(1):119. doi: 10.1186/s13019-020-01155-6.

  PMID: 32460798 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Peter Bramlage, Professor

  CEO IPPMed

  STUDY DIRECTOR

• Ruggero dePaulis, Professor

  European Hospital Rome, Italy

  PRINCIPAL INVESTIGATOR

• Bart Meuris, Professor

  UZ Leuven, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: April 26, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); CA (2); IT (4); DE (2); AU (3); FR (4); BE (1); GB (3); ES (1)