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

NCT07648693 | Recruiting

• 1 other identifier: CHORDS-2025
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Keywords

Cerebral Protection; TAVR; DW-MRI; Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  2-7 days post-procedure

Secondary Outcomes (9)

• The perentage of patient with device success

  Acute post-procedure

• The percentage of patient with procedural success

  Acute post-procedure

• Total new lesion volume in the the protected territories and all territories(DW-MRI)

  2-7 days post-procedure

• Total new lesion volume in the protected territories and all territories(FLAIR-MRI)

  30 days post-procedure

• Change in mRS from baseline

  Discharge (up to 7 days post-procedure), 30 days post-procedure

Study Arms (2)

TAVR+CHORDS

EXPERIMENTAL

Participants undergo TAVR with the CHORDS® Cerebral Protection System

Device: CHORDS® Cerebral Protection System

TAVR+Sentinel

ACTIVE COMPARATOR

Participants undergo TAVR with the Sentinel Cerebral Protection System

Device: Sentinel Cerebral Protection System

Interventions

CHORDS® Cerebral Protection System DEVICE

Undergo TAVR procedure with the CHORDS® Cerebral Protection System

TAVR+CHORDS

Sentinel Cerebral Protection System DEVICE

Undergo TAVR procedure with Sentinel Cerebral Protection System

TAVR+Sentinel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Resonova (Shanghai) Medtech Limited: lead

Study Sites (15)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army

Chongqing, Chongqing Municipality, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Qingdao University Affiliated Hospital

Qingdao, Shandong, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

XU

CONTACT

021-50206611; j.xu@resonmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 15, 2026
• Study Start: October 31, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)