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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

The purpose of the DOUBEL-CHOICE study is to demonstrate non-inferiority of a latest-generation self-expanding valve (SEV) (ACURATE neo2, Boston Scientific, Marlborough, MA, USA) in comparison to another latest-generation SEV (Evolut Pro and Pro+, Medtronic Inc., Minneapolis, MN, USA) and of a minimalist approach vs. standard of care with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05036018
Study type Interventional
Source Leipzig Heart Science gGmbH
Contact Holger Thiele, Prof. Dr.
Phone 0049 341 865
Email holger.thiele@medizin.uni-leipzig.de
Status Recruiting
Phase N/A
Start date August 30, 2021
Completion date October 31, 2033
View Details
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