Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Transcatheter Aortic Valve Implantation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04443023
Collaborators
  • Odense University Hospital
  • Aalborg University Hospital
Investigators
Study Chair: henrik nissen, PhD odense univeristy hospital