PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR)
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|ClinicalTrials.gov Identifier: NCT04149535|
Recruitment Status : Completed
First Posted : November 4, 2019
Results First Posted : February 2, 2023
Last Update Posted : February 2, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Sentinel® Cerebral Protection System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter|
|Actual Study Start Date :||February 7, 2020|
|Actual Primary Completion Date :||February 1, 2022|
|Actual Study Completion Date :||February 1, 2022|
Experimental: TAVR with Sentinel
Patients assigned to this group will undergo TAVR with the Sentinel® Cerebral Protection System.
Device: Sentinel® Cerebral Protection System
cerebral embolic protection system
No Intervention: TAVR without Sentinel
Patients assigned to this group will undergo TAVR without the Sentinel® Cerebral Protection System.
- The Rate of Stroke Through 72 Hours Post TAVR Procedure or Discharge (Whichever Comes First) [ Time Frame: <=72 hours ]All stroke (hemorrhagic, ischemic, or undetermined status; disabling or nondisabling) through 72 hours post TAVR procedure or discharge (whichever comes first), as adjudicated by an independent Clinical Events Committee (CEC) and using Neurologic Academic Research Consortium (NeuroARC) definitions.
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject has documented aortic valve stenosis and is treated with an approved TAVR device via transfemoral access
- Subject has the recommended artery diameter at the site of filter placement per the Sentinel® Cerebral Protection System Instructions For Use: 9-15 mm for the brachiocephalic artery and 6.5-10 mm in the left common carotid artery.
- Subject (or legal representative) provides written informed consent.
- Subject has arterial stenosis >70% in either the left common carotid artery or the brachiocephalic artery.
- Subject's brachiocephalic or left carotid artery reveals significant stenosis, ectasia, dissection, or aneurysm at the aortic ostium or within 3 cm of the aortic ostium.
- Subject has compromised blood flow to the right upper extremity.
- Subject has access vessels with excessive tortuosity.
- Subject has uncorrected bleeding disorders.
- Subject is contraindicated for anticoagulant and antiplatelet therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149535
|Principal Investigator:||Samir Kapadia, MD||The Cleveland Clinic|
Documents provided by Boston Scientific Corporation:
|Responsible Party:||Boston Scientific Corporation|
|Other Study ID Numbers:||
|First Posted:||November 4, 2019 Key Record Dates|
|Results First Posted:||February 2, 2023|
|Last Update Posted:||February 2, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Product Manufactured in and Exported from the U.S.:||Yes|
Central Nervous System Diseases
Nervous System Diseases