Comparison of Eligible TAVI-valves - Cohort B
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- STATUS
- Recruiting
-
- End date
- Dec 31, 2032
-
- participants needed
- 1062
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- sponsor
- Aarhus University Hospital Skejby
Summary
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
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 patients who according to a heart team conference is found eligible for treatment with more than one valve.
- Hypotheses
-
- There is
no difference in the combined endpoint (death,stroke , moderate/severe para-valvular leakage, moderate/severe devicestenosis ) between the two valves to be compared. - There is
no difference between valves in secondary endpoints: death,stroke , moderate/major paravalvular leakage, moderate/severe aortic devicestenosis , new pacemaker implantation, readmission forcongestive heart failure , 6-minute walktest , and degeneration of the valve as evaluated bycomputerized tomography (HCT ),transthoracic echocardiography (TTE ),transesophageal echocardiography (TEE ), or MRI.
- There is
Design: Randomized controlled trial with clinical national registry follow-up.
Centers eligible for inclusion: Scandinavian and European centers who fulfill the above mentioned criteria.
- Randomization
Before randomizing patients, the center decides which two valves the patient is found
eligible for, and enters these valves in the electronic randomization form (TrialPartner).
Randomization is then performed between these two valves. A patient is only randomized if a
dedicated technical
Consecutive cohorts are established.
In the current study we plan to initiate the following cohorts:
Cohort B: Patients randomized to the Sapien or the Myval
Operator requirements:
Any procedure requires that the physician has performed at least 15 implantations with the valve in use. Otherwise the procedure is performed according to the routine of the institution.
Details
Condition | Transcatheter Aortic Valve Implantation |
---|---|
Age | 18years - 100years |
Treatment |
chosen |
Clinical Study Identifier | NCT04443023 |
Sponsor | Aarhus University Hospital Skejby |
Last Modified on | 19 February 2024 |
How to participate?
,
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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