RESPECT PFO Clinical Trial

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ClinicalTrials.gov Identifier: NCT00465270

Recruitment Status : Active, not recruiting

First Posted : April 24, 2007

Last Update Posted : July 21, 2016

Sponsor:

Information provided by (Responsible Party):

St. Jude Medical

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Cryptogenic Stroke	Device: AMPLATZER PFO Occluder Other: Standard of Care - Medical Management	Phase 2

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	980 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
Study Start Date :	August 2003
Actual Primary Completion Date :	December 2011
Estimated Study Completion Date :	December 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Recurrence of nonfatal stroke [ Time Frame: Annually until approved ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:

Related Info This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, Tirschwell DL; RESPECT Investigators. Long-Term Outcomes of Patent Foramen Ovale Closure or Medical Therapy after Stroke. N Engl J Med. 2017 Sep 14;377(11):1022-1032. doi: 10.1056/NEJMoa1610057.

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.


Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00465270 History of Changes
Other Study ID Numbers:	AGA-006 G990318
First Posted:	April 24, 2007 Key Record Dates
Last Update Posted:	July 21, 2016
Last Verified:	July 2016

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

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