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RECRUITING
NCT07648693
NA

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

Sponsor: Resonova (Shanghai) Medtech Limited

View on ClinicalTrials.gov

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

DEVICE

CHORDS® Cerebral Protection System

Undergo TAVR procedure with the CHORDS® Cerebral Protection System

DEVICE

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