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PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149535
Recruitment Status : Completed
First Posted : November 4, 2019
Results First Posted : February 2, 2023
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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Brief Summary:
To demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤72 hours) after transcatheter aortic valve replacement (TAVR).

Condition or disease Intervention/treatment Phase
Stroke Device: Sentinel® Cerebral Protection System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Samir Kapadia, MD The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:
Study Protocol and Statistical Analysis Plan  [PDF] November 6, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04149535    
Other Study ID Numbers: S2453
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)

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases