Status:
ACTIVE_NOT_RECRUITING
Comparison of Eligible TAVI-valves - Cohort B
Lead Sponsor:
Aarhus University Hospital Skejby
Collaborating Sponsors:
Odense University Hospital
Aalborg University Hospital
Conditions:
Transcatheter Aortic Valve Implantation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
Detailed Description
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances. Purpose: To randomize between two TAVI-valve types in ...
Eligibility Criteria
Inclusion
- Patient more than 18 years of age.
- Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference.
- The center experience for each of the valves considered should be more than 15 cases a year, and at least 15 valves implanted before a valve can be used in the trial.
- The center volume should be more than 75 cases a year.
- The patient has given signed informed consent.
- TAVI performed via the femoral artery.
Exclusion
- 1\. Not able to give written inform consent
Key Trial Info
Start Date :
June 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2034
Estimated Enrollment :
1031 Patients enrolled
Trial Details
Trial ID
NCT04443023
Start Date
June 15 2020
End Date
November 2 2034
Last Update
October 31 2024
Active Locations (1)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200