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New treatment option for Stroke
Official title GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
ClinicalTrials.gov ID: NCT03821129
What this study is testing
- What it's testing
- This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days...
- Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or...
- Patient is able to tolerate antiplatelet therapy
- Note: Additional may apply
You likely can't join if
- History of or ongoing atrial fibrillation/flutter
- Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease...
- Previous Myocardial Infarction
- Rankin Scale sore greater than or equal to 3 at the time of procedure
- Active infection that cannot be treated successfully prior to enrollment
- Neurological deficits not due to stroke that may affect the patient's neurologic assessments
See the full eligibility criteria
- Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.
- Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and/or transcranial Doppler (TCD), demonstrating spontaneous right-to-left...
- Patient is able to tolerate antiplatelet therapy
- Note: Additional may apply
- History of or ongoing atrial fibrillation/flutter
- Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion...
- Previous Myocardial Infarction
- Rankin Scale sore greater than or equal to 3 at the time of procedure
- Active infection that cannot be treated successfully prior to enrollment
- Neurological deficits not due to stroke that may affect the patient's neurologic assessments
- Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure
- Sensitivity or contraindication to all proposed medical treatments or any device components
- Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.
- Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.
- Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder
- Need for concomitant procedure(s) that may confound detection of adverse events related to device placement
- Note: Additional Exclusion Criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- La Jolla, California, United States
- Loma Linda, California, United States
- San Francisco, California, United States
- Santa Barbara, California, United States
- Littleton, Colorado, United States
- Loveland, Colorado, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Naples, Florida, United States
- Tampa, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Elk Grove Village, Illinois, United States
- Evanston, Illinois, United States
- Iowa City, Iowa, United States
- West Des Moines, Iowa, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; La Jolla, California, United States; Loma Linda, California, United States; San Francisco, California, United States; Santa Barbara, California, United States; Littleton, Colorado, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.