Transcatheter Aortic Valve Replacement (TAVR)NCT07648693
Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
A study testing CHORDS® Cerebral Protection System and Sentinel Cerebral Protection System in people with Transcatheter Aortic Valve Replacement (TAVR) and Cerebral Vascular Accident (CVA)/Stroke, run by Resonova (Shanghai) Medtech Limited at 15 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke
- What is being tested?
- CHORDS® Cerebral Protection System and Sentinel Cerebral Protection System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 15 sitesChina
- Study dates
- 31 Oct 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Zhang Yingchao, 010-64456966, office@anzhengcp.com
Xinmin Liu
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui
Huan Zhou, 0552-3086943, byyfygcp@163.com
Jinjun Liu
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Zhen Li, 18980601950, huaxigcp@163.com
Jun Shi
- Recruiting
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
Chongqing, Chongqing Municipality
Xie Linli, 023-68766775, cqxnyy@qq.com
Zhihui Zhang
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Cai Xinmei, 0591-86218304, xhyyjgb@163.com
Lianglong Chen
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Wu Anpeng, 87981029, fjydfyjg@163.com
Dajun Chai
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Jiang Faye, 020-83525815, gdphgcp@gdph.org.cn
Jianfang Luo
- Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong
Su Aishan, 020- 62786845, nfyyyw@126.com
Jiancheng Xiu
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Zou Yanqin, 020- 81332371, ywjgbgs@163.com
Yangxin Chen
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Tang Lei, 020-87608185, ctc1983@mail.sysu.edu.cn
Yi Li
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui
Yu Tai, 0551-62283760, ahslyygcp@163.com
Fan Ouyang
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Wen Jinhua, 0791-88695051, ncuyfygcp2018@163.com
Xiaoping Peng
- Recruiting
Qingdao University Affiliated Hospital
Qingdao, Shandong
Cao Yu, 0532-82911767, qingyilunli@126.com
Zhexun Lian
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Yiju Gao, 021-31587861, lcsyjg@zs-hospital.sh.cn
Junbo Ge, MD
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Huang Xiaoxiao, 0577-55579591, wyyy@wzhospital.cn
Hao Zhou
About this study
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
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.
- Being tested
- CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System
- Keywords
- Cerebral Protection, TAVR, DW-MRI, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHORDS® Cerebral Protection SystemDevice
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Sentinel Cerebral Protection SystemDevice
Undergo TAVR procedure with Sentinel Cerebral Protection System
| Study group | Role | What they receive |
|---|---|---|
| TAVR+CHORDS | Experimental | Participants undergo TAVR with the CHORDS® Cerebral Protection System Receives: Device: CHORDS® Cerebral Protection System |
| TAVR+Sentinel | Active comparator | Participants undergo TAVR with the Sentinel Cerebral Protection System Receives: Device: Sentinel Cerebral Protection System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
MACCE: all-cause death, disabling and non-disabling stroke, and Acute Kidney Injury (AKI) Stage 3 or higher at discharge or within7 days post-procedure, whichever occurs first (definitions of all-cause death, stroke, and AKI are based on VARC-3 criteria)
Measured: 30 days post-procedure
Total new lesion volume (TLV, mm³) in protected territories(DW-MRI)
TLV will be assessed by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI). Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery
Measured: 2-7 days post-procedure
Secondary outcomes (9)
The perentage of patient with device success
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
Measured: Acute post-procedure
The percentage of patient with procedural success
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
Measured: Acute post-procedure
Total new lesion volume in the the protected territories and all territories(DW-MRI)
Assessed by DW-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
Measured: 2-7 days post-procedure
Total new lesion volume in the protected territories and all territories(FLAIR-MRI)
Assessed by FLAIR-MRI.Protected territories are defined as the brain territories uniquely perfused by the vessels protected by the study device, namely the left and right carotid arteries, and right vertebral artery.
Measured: 30 days post-procedure
Change in mRS from baseline
Assessed by modified Rankin score
Measured: Discharge (up to 7 days post-procedure), 30 days post-procedure
Change in NIHSS from baseline
Assessed by NIH Stroke Scale
Measured: Discharge (up to 7 days post-procedure), 30 days post-procedure
Incidence of MACCE
MACCE includes:all-cause mortality, disabling and non-disabling stroke, Acute kidney injury(Stage 3 or higher). Definitions follow VARC-3
Measured: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Incidence of major vascular complications
Definitions follow VARC-3
Measured: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Histopathological analysis of captured thrombus/debris
Histopathological analysis includes type, size and number
Measured: Acute post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start31 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Resonova (Shanghai) Medtech Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648693
- Sponsor's protocol ID
- CHORDS-2025
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No