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Clinical Trial Summary

Open-label, 2 x 2 factorial, prospective, randomized, national, multicenter study to compare latest-generation self-expanding valves and isolated local anesthesia versus local anesthesia with conscious sedation 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 isolated local anesthesia in comparison with local anesthesia and conscious sedation with respect to safety and efficacy in patients with severe symptomatic aortic stenosis undergoing transfemoral TAVI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05036018
Study type Interventional
Source Leipzig Heart Science gGmbH
Contact Holger Thiele, Prof. Dr.
Phone +49341865
Email [email protected]
Status Recruiting
Phase N/A
Start date August 30, 2021
Completion date October 31, 2032

See also
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