Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Canada / NCT03666741
Active, not recruiting Observational

Inspiris Resilia Durability Registry

NCT03666741 · tracked via the Priya Life Science Canada tracker
Sponsor
Institut für Pharmakologie und Präventive Medizin
Phase
Observational
Started
2019-04-26
Last updated
2025-06-15

Condition(s) studied

Aortic Valve Stenosis

Investigational drug(s) / intervention(s)

AVR with or without CABG

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

Study 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™.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
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
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

More Institut für Pharmakologie und Präventive Medizin trials in Canada

The ReTAVI Prospective Observational Registry Recruiting

Other trials for the same condition

Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. Recruiting
Valve Hemodynamic Optimization Based on Doppler-Echocardiography vs Catheterization Measurements Following ViV TAVR Recruiting
Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut PRO System for the Treatment of Small, Severely Dysfunctional Surgical Aortic Bioprotheses. The 'LYTEN' Trial Active, not recruiting
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR Recruiting
Translational-Omics in Aortic Stenosis (TOmAS) Biobank Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03666741 on ClinicalTrials.gov ↗ ← All trials in Canada