CHORDS® Cerebral Protection SystemSentinel Cerebral Protection System
CHORDS® Cerebral Protection System: Undergo TAVR procedure with the CHORDS® Cerebral Protection System
Sentinel Cerebral Protection System: Undergo TAVR procedure with Sentinel Cerebral Protection System
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) — 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)
Total new lesion volume (TLV, mm³) in protected territories(DW-MRI) — 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
Trial sites (15)
Facility
City
Region
Status
The First Affiliated Hospital of Bengbu Medical College
Bengbu
Anhui
Recruiting
Anhui Provincial Hospital
Hefei
Anhui
Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Beijing Municipality
Recruiting
The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army
Chongqing
Chongqing Municipality
Recruiting
Fujian Medical University Union Hospital
Fuzhou
Fujian
Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Not Yet Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Guangdong
Recruiting
Southern Medical University Nanfang Hospital
Guangzhou
Guangdong
Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Recruiting
Qingdao University Affiliated Hospital
Qingdao
Shandong
Recruiting
West China Hospital, Sichuan University
Chengdu
Sichuan
Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Zhejiang
Recruiting
Zhongshan Hospital, Fudan University
Shanghai
China
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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