Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

Study Overview
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Brief Summary
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The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.

Official Title
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A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale

Conditions
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Stroke, Patent Foramen Ovale, Ischemic Attack, Transient

Intervention / Treatment
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* Device: STARFlex septal closure system
* Drug: Best medical therapy


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Age 18-60 years inclusive. Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm. Stroke or clinically definite TIA (contact study coordinator). Be able to comply with follow up over two years. Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator. Venous access capable of accepting a 10F minimum vascular sheath. Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study. Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm. Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details. Post-randomization - device patients only The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device. Major Exclusion Criteria: Carotid artery stenosis > 50%. Intracranial stenosis > 50% appropriate to symptoms. Complex aortic arch atheroma with high risk features for embolism Aortic arch, carotid or vertebral artery dissection. Mitral or aortic valve stenosis, vegetation, or calcification > 5 mm mitral annular calcification (MAC) thickness. Active pregnancy. Active infections (contact study coordinator). Active infective endocarditis or bacteremia. Prosthetic heart valves in any location. Anterior MI within 3 months of neurological event. Chronic atrial fibrillation Thrombus in, or occluded, venous access route. Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin. Patient enrolled in another investigation study where clinical endpoint interference may occur. Permanent pacemaker or inferior vena cava (IVC) filter. Serum creatinine > 2.0 mg/dL Patients with known vasculitis or neurologic disorder. Baseline modified Rankin score of 3 or more. Hypercoagulopathies requiring long-term warfarin. Note: Additional exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Best medical therapy | Drug: Best medical therapy<br>* aspirin (325 mg daily) and/or warfarin (target INR = 2.5)<br>|
| Experimental: 2<br>STARFlex arm | Device: STARFlex septal closure system<br>* transcatheter placement of STARFlex device to close a patent foramen ovale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Two (2) year incidence of stroke or Hard TIA |  | 2 years | 
| All cause mortality for the first 30 days of follow up/discharge, whichever is longer |  | 30 days | 
| Neurological mortality from 31 days of follow up (F/U) or longer |  | 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours |  | < 24 hrs | 
| Incidence of primary endpoint in BMT group |  | 2 years | 
| Per treatment group, incidence of relevant/notable adverse events (AEs) |  | 2 years | 
| Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patent Foramen Ovale, STARFlex, CLOSURE I, Septal Closure System, Stroke, Cerebrovascular Accident, Transient Ischemic Attack, Heart Septal Defects, Atrial