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PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement
Overall Recruitment Status: Active, enrollment completed
 
Official Title
PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter
 
Region Sponsors
California - Northern
Boston Scientific/EP Technology
 
Acronym KP IRB No.
1626231
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Child, Adult, Older Adult with documented Stroke and documented aortic valve stenosis
 
Purpose
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)
 
Detailed Description
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
 
Gender Age Limit
Male & Female 1 years & older
 
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

 
Keywords and/or Specific Medical Conditions
  • Brain Diseases
  • S2453
  • Cardiovascular Diseases
  • Stroke
  • Central Nervous System Diseases
  • Vascular Diseases
  • Cerebrovascular Disorders
  • Cardiology
  • Nervous System Diseases
 
KP Clinical Facility
  • San Francisco Medical Center
  • Santa Clara Medical Center-Homestead
 
Clinical Area
  • Cardiology


Principal Investigator:
David Lange, MD
Contact Information:
- Susan Campbell
-susan.campbell@kp.org
-San Francisco Medical Center


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