Inspiris Resilia Durability Registry

Aortic Valve Stenosis Clinical Trial

— INDURE  

Official title:

Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03666741
• Other study ID #: HVT-R18-IND
• Status: Active, not recruiting
• Start date: April 26, 2019
• Est. completion date: May 2025

Study information

• Verified date: June 2023
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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™.

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. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: May 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 60 years inclusive

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:

1. Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery

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

Intraoperative Exclusion criteria:

1. Valve implantation is not possible in accordance with the device IFU

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• AVR with or without CABG
Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™

Locations

Country	Name	City	State
Austria	University Clinics St. Pölten	St. Pölten
Austria	Heart Center Hietzing	Vienna
Austria	Medical University Vienna	Vienna
Belgium	KU Leuven	Leuven
Canada	Institut de Cardiologie de Montréal, Université de Montréal	Montréal
Canada	Laval University	Québec
France	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
Germany	UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie	Freiburg	Baden-Württemberg
Germany	Heart Center Leipzig	Leipzig
Italy	University Hospital Careggi	Florence
Italy	Centro Cardiologico Monzino	Milano
Italy	European Hospital Rome	Roma
Italy	AOU San Giovanni di Dio e Ruggi d'Aragona	Salerno
Netherlands	Erasmus Medisch Centrum	Rotterdam
Spain	University Hospital Virgen de la Arrixaca	Murcia
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Glenfield Hospital	Glenfield
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Freedom from severe SVD (structural valve deterioration)	Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography	Year 5