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Septal Occluder
PFO Closure Device for Preventing Stroke (REDUCE PAS Trial)
N/A
Recruiting
Led By Ignacio Inglessis, MD
Research Sponsored by W.L.Gore & Associates
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Patient is able to tolerate antiplatelet therapy
Must not have
Rankin Scale sore greater than or equal to 3 at the time of procedure
Previous Myocardial Infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the safety and effectiveness of the GORE® CARDIOFORM Septal Occluder in post-approval settings.
Who is the study for?
This trial is for individuals who've had a type of stroke called ESUS within the last year and have a heart condition known as Patent Foramen Ovale (PFO). They must be able to take antiplatelet medication. People with certain heart issues, previous severe strokes, or conditions that increase infection or stroke risk are excluded.
What is being tested?
The study tests the GORE® CARDIOFORM Septal Occluder's safety and effectiveness in preventing recurrent strokes in patients with PFO. It also evaluates how well training for this procedure works outside of clinical trials.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, allergic reactions to device materials, bleeding due to antiplatelet therapy, and risks associated with heart procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with a specific type of stroke by a neurologist within the last year.
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I can safely take medication to prevent blood clots.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need help with my daily activities due to my condition.
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I have had a heart attack before.
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I have a history of or currently have atrial fibrillation/flutter.
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I have neurological issues not caused by a stroke that could affect my brain function tests.
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I am allergic or cannot use certain medications or devices due to health reasons.
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I do not have uncontrolled diabetes, high blood pressure, or a clotting disorder.
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I have an infection that can't be treated before joining the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of subjects with device- or procedure-related serious adverse events at 30 days (Primary Safety Endpoint)
Ischemic stroke
Secondary study objectives
Clinically Significant New Atrial Arrhythmia
Clinically Significant New Atrial Arrhythmia by Age
Effective PFO Closure defined as complete PFO closure or a trivial or small residual shunt by Echocardiographic assessment
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: GORE® CARDIOFORM Septal OccluderExperimental Treatment1 Intervention
Single Arm Commercially available GORE® CARDIOFORM Septal Occluder
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Who is running the clinical trial?
W.L.Gore & AssociatesLead Sponsor
100 Previous Clinical Trials
32,153 Total Patients Enrolled
Ignacio Inglessis, MDPrincipal InvestigatorInterventional Cardiology Associates
John Volpi, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with a specific type of stroke by a neurologist within the last year.You have a specific heart condition that would require using more than one GORE® CARDIOFORM Septal Occluder.I need another medical procedure that might affect the results of a device test.I need help with my daily activities due to my condition.You have a specific heart condition called Patent Foramen Ovale (PFO) that has been confirmed with special heart tests.I have had a heart attack before.I can safely take medication to prevent blood clots.I have a history of or currently have atrial fibrillation/flutter.I have neurological issues not caused by a stroke that could affect my brain function tests.I am allergic or cannot use certain medications or devices due to health reasons.I do not have uncontrolled diabetes, high blood pressure, or a clotting disorder.I have serious heart or blood vessel conditions, or other health issues that could increase my risk during the study.I have an infection that can't be treated before joining the trial.Your heart condition is not suitable for the device placement because of certain congenital anomalies or if the defect in your heart is too big.
Research Study Groups:
This trial has the following groups:- Group 1: GORE® CARDIOFORM Septal Occluder
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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