Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

RESPECT PFO Clinical Trial

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AGA Medical Corporation Identifier:
First received: April 23, 2007
Last updated: August 20, 2014
Last verified: August 2014

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.

Condition Intervention Phase
Cryptogenic Stroke
Device: AMPLATZER PFO Occluder
Other: Standard of Care - Medical Management
Phase 2

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment

Further study details as provided by AGA Medical Corporation:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Complete closure of the defect demonstrated by TEE and bubble study (device group). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 980
Study Start Date: August 2003
Estimated Study Completion Date: March 2015
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Device: AMPLATZER PFO Occluder
patent foramen ovale closure device
Active Comparator: 2
Medical Management
Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00465270

  Show 69 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
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
  More Information

Additional Information:
No publications provided by AGA Medical Corporation

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AGA Medical Corporation Identifier: NCT00465270     History of Changes
Other Study ID Numbers: AGA-006, G990318
Study First Received: April 23, 2007
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:

Additional relevant MeSH terms:
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases processed this record on November 20, 2014