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.
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 …
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