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RESPECT PFO Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00465270
First received: April 23, 2007
Last updated: May 15, 2012
Last verified: January 2012
History of Changes

April 23, 2007
May 15, 2012
August 2003
August 2012   (final data collection date for primary outcome measure)
Recurrence of nonfatal stroke [ Time Frame: Annually until approved ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00465270 on ClinicalTrials.gov Archive Site
Complete closure of the defect demonstrated by TEE and bubble study (device group). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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: 1
    AMPLATZER PFO Occluder
    Intervention: Device: AMPLATZER PFO Occluder
  • Active Comparator: 2
    Medical Management
    Intervention: Other: Standard of Care - Medical Management
Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013 Mar 21;368(12):1092-100. doi: 10.1056/NEJMoa1301440.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
900
Not Provided
August 2012   (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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00465270
AGA-006, G990318
Yes
AGA Medical Corporation
AGA Medical Corporation
Not Provided
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
AGA Medical Corporation
January 2012

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