Status:
RECRUITING
Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
Lead Sponsor:
Erasmus Medical Center
Conditions:
Valve Heart Disease
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed ...
Eligibility Criteria
Inclusion
- Age ≥ 65 years
- Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
- Written informed consent
Exclusion
- Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
- Multi-valve defects requiring intervention
- Clinically unstable and/or inotropic/vasopressor /mechanical support.
- Known mural thrombus in the left ventricle
- Presence of a mechanical aortic valve
- History of recent (within 1 month) stroke or TIA
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04843072
Start Date
May 1 2021
End Date
May 1 2026
Last Update
July 27 2022
Active Locations (14)
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1
Cedars Sinai
Los Angeles, California, United States, 90048
2
Vienna General Hospital
Vienna, Austria
3
St Paul's and Vancouver General Hospital
Vancouver, Canada
4
Rigshospitalet
Copenhagen, Denmark