Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

RESPECT PFO Clinical Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00465270
First received: April 23, 2007
Last updated: July 20, 2016
Last verified: July 2016

April 23, 2007
July 20, 2016
August 2003
December 2011   (final data collection date for primary outcome measure)
Recurrence of nonfatal stroke [ Time Frame: Annually until approved ] [ Designated as safety issue: No ]
25 Primary endpoints of reoccurent nonfatal stroke triggers end of enrollment
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.
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.
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: 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
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
980
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
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00465270
AGA-006, G990318
Yes
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
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
St. Jude Medical
July 2016

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