Clinical trials related to Transcatheter Aortic Valve Replacement (TAVR) Procedure
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
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 without significant stenosis (\> 70%)
• Patients who are able to understand the study objectives, voluntarily participate, sign the informed consent form, and are willing to undergo required examinations and clinical follow-up.
Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical College
RECRUITING
Bengbu
West China Hospital, Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
RECRUITING
Chongqing
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
Anhui Provincial Hospital
RECRUITING
Hefei
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Qingdao University Affiliated Hospital
RECRUITING
Qingdao
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Contact Information
Primary
XU
j.xu@resonmed.com
021-50206611
Time Frame
Start Date:2025-10-31
Estimated Completion Date:2026-12-31
Participants
Target number of participants:240
Treatments
Experimental: TAVR+CHORDS
Participants undergo TAVR with the CHORDS® Cerebral Protection System
Active_comparator: TAVR+Sentinel
Participants undergo TAVR with the Sentinel Cerebral Protection System