Testing a brain protection device during transcatheter aortic valve replacement
Compares two brain protection devices that catch debris during heart valve replacement.
Plain-language title generated from the registry record
Registry title: Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
Key facts
- Where
- Beijing, Bengbu, Chengdu, Chongqing, Fuzhou, Guangzhou, Hefei, Nanchang, Qingdao, Shanghai, and Wenzhou, ChinaSee the 15 sites
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- The First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation ArmyChongqing, ChinaTaking people
- Fujian Medical University Union HospitalFuzhou, ChinaTaking people
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaNot yet recruiting
- Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
- Southern Medical University Nanfang HospitalGuangzhou, ChinaTaking people
- Sun Yat Sen Memorial Hospital of Sun Yat sen UniversityGuangzhou, ChinaTaking people
- the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaTaking people
- Anhui Provincial HospitalHefei, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
- Qingdao University Affiliated HospitalQingdao, ChinaTaking people
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Resonova (Shanghai) Medtech Limited
- Trial code
- NCT07648693
- Record updated
- 15 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Acute myocardial infarction ≤ 30 days before the intended treatment; 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; 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; Pure aortic regurgitation; Pre-existing prosthetic aortic valve; Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation; 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.