Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• Patient more than 18 years of age.
• Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia 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 the treating physician should have implanted at least 15 of each valve 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.
Locations
Other Locations
Denmark
Department of cardiology, Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Christian J Terkelsen, Professor
CHRITERK@RM.DK
+4540135388
Backup
Helle Bargsteen
hellbarg@rm.dk
+4578452112
Time Frame
Start Date: 2024-08-09
Estimated Completion Date: 2036-12-01
Participants
Target number of participants: 1346
Treatments
Active_comparator: Medtronic Evolut FX
TAVI procedure performed with Medtronic Evolut FX
Active_comparator: Edwards Sapien Ultra 3 Resilia
TAVI procedure performed with Edwards Sapien Ultra 3 Resilia
Related Therapeutic Areas
Sponsors
Leads: Christian Juhl Terkelsen
Collaborators: Department of Clinical Epidemiology, Aarhus University, DK-8200 Aarhus N, Denmark