RESPECT PFO Clinical Trial
This study is ongoing, but not recruiting participants.
Sponsor:
St. Jude Medical
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
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Purpose
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 St. Jude Medical:
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: | December 2016 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Device
AMPLATZER PFO Occluder
|
Device: AMPLATZER PFO Occluder
patent foramen ovale closure device
|
|
Active Comparator: Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
|
Other: Standard of Care - Medical Management
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier: NCT00465270
Show 69 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465270
Show 69 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
| 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Jude Medical |
| ClinicalTrials.gov Identifier: | NCT00465270 History of Changes |
| Other Study ID Numbers: | AGA-006 G990318 |
| Study First Received: | April 23, 2007 |
| Last Updated: | July 20, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Medical:
|
Cryptogenic Stroke PFO |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 26, 2016