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

Resonova (Shanghai) Medtech Limited240 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

240

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (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

...and 5 more locations

Outcomes

Primary Outcomes

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-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

Time frame: 2-7 days post-procedure

Secondary Outcomes

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-procedure

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-procedure

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-procedure

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-procedure

Change in mRS from baseline

Assessed by modified Rankin score

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

Change in NIHSS from baseline

Assessed by NIH Stroke Scale

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

Incidence of MACCE

MACCE includes:all-cause mortality, disabling and non-disabling stroke, Acute kidney injury(Stage 3 or higher). Definitions follow VARC-3

Time frame: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure

Incidence of major vascular complications

Definitions follow VARC-3

Time frame: Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure

Histopathological analysis of captured thrombus/debris

Histopathological analysis includes type, size and number

Time frame: Acute post-procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (15)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts