Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHORDS® Cerebral Protection System, Sentinel Cerebral Protection System.
- Who it may be relevant to
- Registry conditions: Transcatheter Aortic Valve Replacement (TAVR), Cerebral Vascular Accident (CVA)/Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device CHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System - Device Sentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System
Primary outcome measures
- Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) [Time frame: 30 days post-procedure]
- Total new lesion volume (TLV, mm³) in protected territories(DW-MRI) [Time frame: 2-7 days post-procedure]
Secondary outcome measures (9)
- The perentage of patient with device success [Time frame: Acute post-procedure]
- The percentage of patient with procedural success [Time frame: Acute post-procedure]
- Total new lesion volume in the the protected territories and all territories(DW-MRI) [Time frame: 2-7 days post-procedure]
- Total new lesion volume in the protected territories and all territories(FLAIR-MRI) [Time frame: 30 days post-procedure]
- Change in mRS from baseline [Time frame: 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]
- Incidence of MACCE [Time frame: 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]
- Histopathological analysis of captured thrombus/debris [Time frame: Acute post-procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 15 centers
- The First Affiliated Hospital of Bengbu Medical College — Bengbu
- Anhui Provincial Hospital — Hefei
- Beijing Anzhen Hospital, Capital Medical University — Beijing
- The First Affiliated Hospital of the Army Medical University of the Chinese People's Liber — Chongqing
- Fujian Medical University Union Hospital — Fuzhou
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
- Guangdong Provincial People's Hospital — Guangzhou
- Southern Medical University Nanfang Hospital — Guangzhou
- … and 7 more centers
Identifiers
NCT: NCT07648693 · CHORDS-2025