Evaluation of the Safety and Effectiveness of CHORDS® Cerebral Protection System During TAVR: DUET Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResonova (Shanghai) Medtech Limited
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
CHORDS® Cerebral Protection System
DeviceUndergo TAVR procedure with the CHORDS® Cerebral Protection System
Sentinel Cerebral Protection System
DeviceUndergo TAVR procedure with Sentinel Cerebral Protection System
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: TAVR+CHORDSExperimental treatment 1 intervention
Group B: TAVR+SentinelActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
30 days post-procedure2
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
Time frame
2-7 days post-procedureSecondary outcomes
1
The perentage of patient with device success
Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device
Time frame
Acute post-procedure2
The percentage of patient with procedural success
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
Time frame
Acute post-procedure3
Total new lesion volume in the the protected territories and all territories(DW-MRI)
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.
Time frame
2-7 days post-procedure4
Total new lesion volume in the protected territories and all territories(FLAIR-MRI)
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.
Time frame
30 days post-procedureSponsors and contacts
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Source ClinicalTrials.gov