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

June 12, 2026 updated by: Resonova (Shanghai) Medtech Limited

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Zhongshan Hospital, Fudan University
        • Principal Investigator:
          • Junbo Ge, MD
        • Contact:
        • Sub-Investigator:
          • Wenzhi Pan, MD
    • Anhui
      • Bengbu, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
        • Principal Investigator:
          • Jinjun Liu
      • Hefei, Anhui, China
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Fan Ouyang
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Xinmin Liu
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Recruiting
        • The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
        • Principal Investigator:
          • Zhihui Zhang
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
        • Principal Investigator:
          • Lianglong Chen
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Dajun Chai
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Jianfang Luo
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Yi Li
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Southern Medical University Nanfang Hospital
        • Principal Investigator:
          • Jiancheng Xiu
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Yangxin Chen
        • Principal Investigator:
          • Haifeng Zhang
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Xiaoping Peng
        • Contact:
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Qingdao University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Zhexun Lian
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital, Sichuan University
        • Principal Investigator:
          • Jun Shi
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Hao Zhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAVR+CHORDS
Participants undergo TAVR with the CHORDS® Cerebral Protection System
Device: CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Active Comparator: TAVR+Sentinel
Participants undergo TAVR with the Sentinel Cerebral Protection System
Device: Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 30 days post-procedure
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)
30 days post-procedure
Total new lesion volume (TLV, mm³) in protected territories(DW-MRI)
Time Frame: 2-7 days post-procedure
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
2-7 days post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The perentage of patient with device success
Time Frame: Acute post-procedure
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
Acute post-procedure
The percentage of patient with procedural success
Time Frame: Acute post-procedure
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
Acute post-procedure
Total new lesion volume in the the protected territories and all territories(DW-MRI)
Time Frame: 2-7 days post-procedure
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.
2-7 days post-procedure
Total new lesion volume in the protected territories and all territories(FLAIR-MRI)
Time Frame: 30 days post-procedure
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.
30 days post-procedure
Change in mRS from baseline
Time Frame: Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by modified Rankin score
Discharge (up to 7 days post-procedure), 30 days post-procedure
Change in NIHSS from baseline
Time Frame: Discharge (up to 7 days post-procedure), 30 days post-procedure
Assessed by NIH Stroke Scale
Discharge (up to 7 days post-procedure), 30 days post-procedure
Incidence of MACCE
Time Frame: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
MACCE includes:all-cause mortality, disabling and non-disabling stroke, Acute kidney injury(Stage 3 or higher). Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Incidence of major vascular complications
Time Frame: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Definitions follow VARC-3
Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure
Histopathological analysis of captured thrombus/debris
Time Frame: Acute post-procedure
Histopathological analysis includes type, size and number
Acute post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Resonova (Shanghai) Medtech Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 6, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHORDS-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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