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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR+CHORDS | Experimental | Participants undergo TAVR with the CHORDS® Cerebral Protection System |
|
| TAVR+Sentinel | Active Comparator | Participants undergo TAVR with the Sentinel Cerebral Protection System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHORDS® Cerebral Protection System | Device | Undergo TAVR procedure with the CHORDS® Cerebral Protection System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 2-7 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The perentage of patient with device success | Successful delivery, deployment both distal and proximal filters in appropriate anatomical locations, and retrieval of the device | Acute post-procedure |
| The percentage of patient with procedural success |
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Inclusion Criteria:
Exclusion Criteria:
General
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XU | Contact | 021-50206611 | j.xu@resonmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Recruiting | Bengbu | Anhui | China |
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| Sentinel Cerebral Protection System | Device | Undergo TAVR procedure with Sentinel Cerebral Protection System |
|
Successful deployment of at least one filter during the TAVR procedure, without the occurrence of an device-related MACCE
| 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. | 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. | 30 days post-procedure |
| Change in mRS from baseline | Assessed by modified Rankin score | Discharge (up to 7 days post-procedure), 30 days post-procedure |
| Change in NIHSS from baseline | Assessed by NIH Stroke Scale | 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 | Discharge (up to 7 days post-procedure), 30 days, and 90 days post-procedure |
| Incidence of major vascular complications | Definitions follow VARC-3 | 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 | Acute post-procedure |
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | China |
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| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| The First Affiliated Hospital of the Army Medical University of the Chinese People's Liberation Army | Recruiting | Chongqing | Chongqing Municipality | China |
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| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
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| The First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Southern Medical University Nanfang Hospital | Recruiting | Guangzhou | Guangdong | China |
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| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| Qingdao University Affiliated Hospital | Recruiting | Qingdao | Shandong | China |
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| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| The First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
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| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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