Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
400 participants
OBSERVATIONAL
2019-04-26
2026-07-31
Brief Summary
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Detailed Description
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The novel tissue preservation technology significantly improves hemodynamic and anticalcification properties compared with the standard Perimount valve in an ovine model. In this registry, data is collected over a period of 5 years to demonstrate these properties in a clinical real-life setting. Clinical outcomes, hemodynamic as well as safety parameters and quality of life data are documented into e-CRF at baseline, surgery, pre-discharge, 3-6 months and annually up to year 5.
The required sample size was calculated using the online calculator at http://www.surveysystem.com/sscalc.htm. It was estimated, from COMMENCE Trial dataset that freedom from time-related valve safety events at 1 year (composite endpoint according to VARC-2) is around 0.915. The following table illustrates 95% CIs at different levels of risk:
Sample Size Observed freedom from event 95%CI 400 0.900 ± 0.0294 400 0.910 ± 0.0280 400 0.915 ± 0.0214 400 0.920 ± 0.0266 400 0.930 ± 0.0250
20% of registry sites will be monitored with 100% source data verification
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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AVR with or without CABG
Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™
Eligibility Criteria
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Inclusion Criteria
2. Subject requiring a planned replacement of their native aortic valve as indicated in a preoperative evaluation
3. Subject is scheduled to undergo planned aortic valve replacement with or without concomitant root replacement and/or coronary bypass surgery
4. Subject is scheduled to attend yearly follow-up visits at the registry center up to 5 years follow-up
5. Subject provides written informed consent prior to the procedure
Exclusion Criteria
2. Previous aortic valve replacement
3. Valve implantation is not possible in accordance with the device IFU
4. Subject has a life expectancy ≤ 12 months for any reason
1\. Valve implantation is not possible in accordance with the device IFU
18 Years
60 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Peter Bramlage, Professor
Role: STUDY_DIRECTOR
CEO IPPMed
Ruggero dePaulis, Professor
Role: PRINCIPAL_INVESTIGATOR
European Hospital Rome, Italy
Bart Meuris, Professor
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven, Belgium
Locations
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University Clinics St. Pölten
Sankt Pölten, , Austria
Heart Center Hietzing
Vienna, , Austria
Medical University Vienna
Vienna, , Austria
KU Leuven
Leuven, , Belgium
Institut de Cardiologie de Montréal, Université de Montréal
Montreal, , Canada
Laval University
Québec, , Canada
Hopital de la Timone
Marseille, , France
L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes)
Nantes, , France
Centre Hospitalier Universitaire (CHU) de Rennes
Rennes, , France
CHRU - Hospital Trousseau
Tours, , France
UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heart Center Leipzig
Leipzig, , Germany
University Hospital Careggi
Florence, , Italy
Centro Cardiologico Monzino
Milan, , Italy
European Hospital Rome
Roma, , Italy
AOU San Giovanni di Dio e Ruggi d'Aragona
Salerno, , Italy
Erasmus Medisch Centrum
Rotterdam, , Netherlands
University Hospital Virgen de la Arrixaca
Murcia, , Spain
NHS Lothian
Edinburgh, , United Kingdom
Glenfield Hospital
Glenfield, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HVT-R18-IND
Identifier Type: -
Identifier Source: org_study_id
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