Status:
NOT_YET_RECRUITING
Optimization of Commissural Alignment During Transcatheter Aortic Valve Implantation With Evolut FX+
Lead Sponsor:
Oslo University Hospital
Conditions:
Aortic Stenosis
Trans-catheter Aortic Valve Implantation
Eligibility:
All Genders
Phase:
NA
Brief Summary
Purpose of the Study The purpose of this study is to investigate how a transcatheter aortic valve (TAVI, biological valve prosthesis) can best be positioned in order to avoid blockage of the coronary ...
Detailed Description
The purpose of the present study is to prospectively evaluate the efficacy and safety of a novel patient-specific rotation of the Evolut FX+ TAVI valve and the delivering system during the transfemora...
Eligibility Criteria
Inclusion
- Patients with severe aortic stenosis indicated for TAVI after heart team meeting.
- Age ≥65 years.
- Patients planned by the TAVI team to receive a self-expandable valve (Evolut FX+ valve).
- Patients providing informed consent.
Exclusion
- Severe peripheral vascular disease preventing transfemoral access.
- Prior aortic valve replacement or bicuspid valve.
- Severely reduced kidney function (estimated glomerular filtration rate \<30).
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07217691
Start Date
November 1 2025
End Date
May 1 2026
Last Update
October 16 2025
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