Inspiris Resilia Durability Registry

Active, not recruiting

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03666741
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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™.

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. 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

Study Timeline

• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2019-04-26
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-22
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time-related valve safety	Year 1	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
Freedom from severe SVD (structural valve deterioration)	Year 5	Freedom from stage 3 SVD including stenosis and regurgitation determined by echocardiography

Trial Locations

Locations (21)

Hopital de la Timone; 🇫🇷 Marseille, France

University Hospital Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Glenfield Hospital; 🇬🇧 Glenfield, United Kingdom

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Centro Cardiologico Monzino; 🇮🇹 Milano, Italy

AOU San Giovanni di Dio e Ruggi d'Aragona; 🇮🇹 Salerno, Italy

Centre Hospitalier Universitaire (CHU) de Rennes; 🇫🇷 Rennes, France

Laval University; 🇨🇦 Québec, Canada

L'institut du thorax - CHU (Centre Hospitalier Universitaire de Nantes); 🇫🇷 Nantes, France

Institut de Cardiologie de Montréal, Université de Montréal; 🇨🇦 Montréal, Canada

UNIVERSITÄTSKLINIKUM FREIBURG, Universitäts-Herzzentrum Herz- und Gefäßchirurgie; 🇩🇪 Freiburg, Baden-Württemberg, Germany

CHRU - Hospital Trousseau; 🇫🇷 Tours, France

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

University Hospital Careggi; 🇮🇹 Florence, Italy

European Hospital Rome; 🇮🇹 Roma, Italy

Heart Center Hietzing; 🇦🇹 Vienna, Austria

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

University Clinics St. Pölten; 🇦🇹 St. Pölten, Austria

Medical University Vienna; 🇦🇹 Vienna, Austria

KU Leuven; 🇧🇪 Leuven, Belgium