Comparison of Eligible TAVI-valves - Cohort B
-
- STATUS
- Recruiting
-
- End date
- Dec 31, 2032
-
- participants needed
- 1062
-
- 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 device stenosis) 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 device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.
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 TAVI conference has found the patient eligible for treatment with both valves.
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 TAVI valve.
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 | 18-100 years |
| Treatment | chosen TAVI valve |
| Clinical Study Identifier | NCT04443023 |
| Sponsor | Aarhus University Hospital Skejby |
| Last Modified on | 19 February 2024 |
How to participate?
,
You have contacted , on
Your message has been sent to the study team at ,
What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
You are contacting
Primary Contact
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.
Learn moreSimilar trials to consider
Browse trials for
Not finding what you're looking for?
Sign up as a volunteer to stay informed
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.
Sign up as volunteer
Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!
No annotations made yet
Add a private note
- Select a piece of text from the left.
- Add notes visible only to you.
- Send it to people through a passcode protected link.
Study Definition
WikipediaAdd a private note
- Select a piece of text.
- Add notes visible only to you.
- Send it to people through a passcode protected link.