Status:
ACTIVE_NOT_RECRUITING
SAVR: IMPACT of Pre-existing Comorbidities on Patient Outcomes and Prosthetic Valve Performance in a Real-world Setting.
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Collaborating Sponsors:
Edwards Lifesciences
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
The IMPACT Registry represents a non-interventional, prospective, open-label, multicenter, international registry with a follow-up of 5 years that includes data of patients undergoing aortic valve rep...
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 Preservatio...
Eligibility Criteria
Inclusion
- Patient is at least 18 years old
- Patient has an aortic valve vitium and requires an aortic valve replacement with the Edwards INSPIRIS RESILIA Aortic Valve™
- Patient is scheduled to attend yearly follow-up visits at the registry center up to 5 years
- Patient provides written informed consent prior to the procedure and in case of emergency after the procedure.
Exclusion
- Disability and / or other circumstances under which the patient is not capable to understand the nature, significance and scope of the clinical trial
- Active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- Patient has a life expectancy ≤ 12 months for any reason
- Valve implantation is not possible in accordance with the device IFU
- Pregnancy
Key Trial Info
Start Date :
December 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04053088
Start Date
December 12 2019
End Date
August 1 2026
Last Update
June 12 2025
Active Locations (22)
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1
Medizinische Universität Innsbruck, Uniklinik für Herzchirurgie
Innsbruck, Austria
2
Kepler Universitätsklinikum Linz
Linz, Austria, 4021
3
• Universitätsklinikum Salzburg, Herzchirurgie, Gefäßchirurgie und endovaskuläre Chirurgie
Salzburg, Austria
4
• Klinikum Wels-Grieskirchen, Herz-, Gefäß- und Thoraxchirurgie
Wels, Austria