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Clinical Trials in China / NCT07648693
Recruiting

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

NCT07648693 · tracked via the Priya Life Science China tracker
Sponsor
Resonova (Shanghai) Medtech Limited
Phase
N/A
Started
2025-10-31
Last updated
2026-06-15

Condition(s) studied

Transcatheter Aortic Valve Replacement (TAVR)Cerebral Vascular Accident (CVA)/Stroke

Investigational drug(s) / intervention(s)

CHORDS® Cerebral Protection SystemSentinel Cerebral Protection System

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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. Exclusion Criteria: General * Contraindications to MRI, or planned implantation of an MRI-incompatible device at the index procedure, or planned implantation of an MRI-incompatible pacemaker or defibrillator within 30 days post-procedure. * Acute myocardial infarction ≤ 30 days before the intended treatment * Pure aortic regurgitation * Pre-existing prosthetic aortic valve * Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation * Contraindication to antiplatelet and/or anticoagulant therapy, nitinol , or contrast media, or refusal to receive blood transfusions * Vulnerable populations, including those unable to adequately understand the trial, those potentially subject to undue influence or coercion, those unable to complete the informed consent process, and those with severe disabling dementia or cognitive impairment Anatomic * Vasculature (ie, right radial/brachial artery, carotid artery) precluding the device access * Patients whose brachiocephalic or left carotid artery reveals significant stenosis(\>70%), ectasia, dissection, or aneurysm at the ostium or within 3 cm of the ostium

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui Recruiting
Anhui Provincial Hospital Hefei Anhui Recruiting
Beijing Anzhen Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army Chongqing Chongqing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Guangdong Provincial People's Hospital Guangzhou Guangdong Recruiting
Southern Medical University Nanfang Hospital Guangzhou Guangdong Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Qingdao University Affiliated Hospital Qingdao Shandong Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Zhongshan Hospital, Fudan University Shanghai China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07648693 on ClinicalTrials.gov ↗ ← All trials in China