RESPECT PFO Clinical Trial

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. Identifier: NCT00465270
Recruitment Status : Unknown
Verified July 2016 by St. Jude Medical.
Recruitment status was:  Active, not recruiting
First Posted : April 24, 2007
Last Update Posted : July 21, 2016
Information provided by (Responsible Party):
St. Jude Medical

April 23, 2007
April 24, 2007
July 21, 2016
August 2003
December 2011   (Final data collection date for primary outcome measure)
Recurrence of nonfatal stroke [ Time Frame: Annually until approved ]
25 Primary endpoints of reoccurent nonfatal stroke triggers end of enrollment
Not Provided
Complete list of historical versions of study NCT00465270 on Archive Site
Complete closure of the defect demonstrated by TEE and bubble study (device group). [ Time Frame: 6 months ]
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RESPECT PFO Clinical Trial
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Cryptogenic Stroke
  • Device: AMPLATZER PFO Occluder
    patent foramen ovale closure device
  • Other: Standard of Care - Medical Management
    Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
  • Experimental: Device
    AMPLATZER PFO Occluder
    Intervention: Device: AMPLATZER PFO Occluder
  • Active Comparator: Standard or Care - Medical Management
    Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
    Intervention: Other: Standard of Care - Medical Management

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
December 2016
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who have had a cryptogenic stroke within the last 270 days
  • Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
  • Subjects willing to participate in follow-up visits

Exclusion Criteria:

  • Subjects with intracardiac thrombus or tumor
  • Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
  • Subjects with left ventricular aneurysm or akinesis
  • Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
  • Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
  • Subjects with contraindication to aspirin or Clopidogrel therapy
  • Pregnant or desire to become pregnant within the next year
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
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St. Jude Medical
St. Jude Medical
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Principal Investigator: Jeffrey Saver, MD UCLA Stroke Center
Principal Investigator: John D Carroll, MD University of Colorado, Denver
Principal Investigator: Richard Smalling, MD University of Texas Houston Health Science Center
Principal Investigator: David Thaler, MD Tufts Medical Center
St. Jude Medical
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP