Clinical Trial

RanDOmized stUdy Comparing Both Latest Generation Self-Expanding Valves and a Minimalist approaCH vs. Standard Of Care In transCathEter Aortic Valve Implantation

Study acronym: DOUBLE-CHOICE
Active, Not Recruiting
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Summary
Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and a minimalist approach versus standard of care in transcatheter aortic valve implantation.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2021-08-30; most recent amendment 2026-02-10.
Status change: Recruiting → Active, Not Recruiting 2025-01-15
Trial Details
NCT Number NCT05036018
Lead Sponsor Leipzig Heart Science gGmbH
Collaborators: Heart Center Leipzig - University Hospital
Conditions Aortic Valve Stenosis
Enrollment 836 participants
Start Date 2021-08-30
Primary Completion 2025-03-31 (estimated)
Study Completion 2035-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-11