Clinical Research Directory
Browse clinical research sites, groups, and studies.
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
Sponsor: Resonova (Shanghai) Medtech Limited
Summary
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® Cerebral Protection System (Test group) or the Sentinel System (Control group).All the participants will be followed up at 30 days and 90 days post-procedure.
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Safety and Effectiveness of the Resonova® CHORDS® Cerebral Protection System in Capturing and Removing Embolic Debris During Transcatheter Aortic Valve Replacement
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-10-31
Completion Date
2026-12-31
Last Updated
2026-06-15
Healthy Volunteers
No
Interventions
CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System
Locations (15)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Qingdao University Affiliated Hospital
Qingdao, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Zhongshan Hospital, Fudan University
Shanghai, China