This trial is active, not recruiting.

Condition cryptogenic stroke
Treatments amplatzer pfo occluder, standard of care - medical management
Phase phase 2
Sponsor St. Jude Medical
Start date August 2003
End date December 2011
Trial size 980 participants
Trial identifier NCT00465270, AGA-006, G990318


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
amplatzer pfo occluder
patent foramen ovale closure device
(Active Comparator)
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
standard of care - medical management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Primary Outcomes

Recurrence of nonfatal stroke
time frame: Annually until approved

Secondary Outcomes

Complete closure of the defect demonstrated by TEE and bubble study (device group).
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
Principal investigator Jeffrey Saver, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.