Cerebral Vascular Accident (CVA)/Stroke, Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Keywords
Cerebral Protection, TAVR, DW-MRI, Stroke
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.
Interventions
DEVICECHORDS® Cerebral Protection System
Undergo TAVR procedure with the CHORDS® Cerebral Protection System
DEVICESentinel Cerebral Protection System
Undergo TAVR procedure with Sentinel Cerebral Protection System
Sponsors
Resonova (Shanghai) Medtech Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The perentage of patient with device success | Acute post-procedure | Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device |
| The percentage of patient with procedural success | Acute post-procedure | Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE |
| Total new lesion volume in the the protected territories and all territories(DW-MRI) | 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. |
| Total new lesion volume in the protected territories and all territories(FLAIR-MRI) | 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. |
| Change in mRS from baseline | Discharge (up to 7 days post-procedure), 30 days post-procedure | Assessed by modified Rankin score |
| Change in NIHSS from baseline | Discharge (up to 7 days post-procedure), 30 days post-procedure | Assessed by NIH Stroke Scale |
| Incidence of MACCE | 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 |
| Incidence of major vascular complications | Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure | Definitions follow VARC-3 |
| Histopathological analysis of captured thrombus/debris | Acute post-procedure | Histopathological analysis includes type, size and number |
Countries
China
Contacts
CONTACTXU
Outcome results
None listed