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AMPLATZER PFO Occluder Post Approval Study
Overall Recruitment Status: Active, currently enrolling
 
Official Title
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
 
Region Sponsors
California - Southern
Abbott Medical Devices
St. Jude Medical
 
Acronym KP IRB No.
(PFO PAS) 11496
 
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
 
Study Population Description
(Adult) with documented evidence of Stroke, Patent Foramen Ovale
 
Purpose
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZERâ„¢ PFO Occluder in the post Approval Setting.
 
Detailed Description
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant
 
Gender Age Limit
Male & Female 18 - 60 years
 
Inclusion Criteria
  • Subjects with a PFO who have had an ischemic stroke within the last 547 days
 
Exclusion Criteria
  • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a > 50% lumen diameter supplying the involved lesion
  • Intra-cardiac thrombus or tumor
  • Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
  • Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
  • Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding greater than 4mm into the aortic lumen Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)
  • Subjects with other source of right to left shunts, including an atrial septal defect and/or fenestrated septum
  • Chronic, persistent, or paroxysmal atrial fibrillation or atrial flutter Pregnancy at the time of implant
  • Age less than 18 years or greater than 60 years at time of consent Active endocarditis or other untreated infections
  • Organ failure (kidney, liver or lung) Kidney failure: Poor urine output of less than 1 cc/kg/hr with elevated BUN levels (above the normal reference range for the laboratory at the investigational site)
  • Uncontrolled hypertension defined as sustained elevated systemic blood pressure to more than 160/90 mmHg with medications
  • Please contact study personnel for more eligibility criteria

 
Keywords and/or Specific Medical Conditions
  • Cardiovascular Abnormalities
  • Heart Diseases
  • Cardiovascular Diseases
  • Heart Septal Defects
  • Congenital Abnormalities
  • Heart Septal Defects, Atrial
  • Foramen Ovale, Patent
  • Stroke
  • Heart Defects, Congenital
  • Cardiology
 
KP Clinical Facility
  • Edgemont MOB
  • Los Angeles (Sunset)
 
Clinical Area
  • Cardiology


Principal Investigator:
Somjot Brar, MD
Contact Information:
- Tiffany Castanon
-626-564-5667
-Los Angeles (Sunset)


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