Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial

Recruiting N/A Interventional Study
Transcatheter Aortic Valve Replacement (TAVR) Cerebral Vascular Accident (CVA)/Stroke
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
240 (estimated)
Sponsor
Resonova (Shanghai) Medtech Limited · Industry
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About This Trial
This is a prospective, multi-center, randomized controlled study. The goal of the study is to assess the safety and effectiveness of the Resonova® CHORDS® Cerebral Protection System in capturing and removing embolic debris during Transcatheter Aortic Valve Replacement (TAVR). A total of 240 eligible participants will be enrolled and randomized in a 1:1 ratio to undergo TAVR either with the CHORDS®…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male or non-pregnant female, ≥18 years * Patients with symptomatic severe aortic stenosis who are scheduled to undergo TAVR with commercialized transcatheter aortic valve system. * Compatible left common carotid artery (6.5-10 mm) and brachiocephalic artery (9-15mm) diameters …
Contacts

XU

021-50206611

j.xu@resonmed.com

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