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
Last Update Posted : July 28, 2022
|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.
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|