Status:
COMPLETED
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Lead Sponsor:
University of Florida
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to compare a minimally invasive surgical procedure and medication management in stroke patients with Atrial Fibrillation. The two treatment options are a minimally invasiv...
Detailed Description
Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation
Eligibility Criteria
Inclusion
- Patients with a history of stroke and paroxysmal, persistent or permanent AF.
- Ischemic stroke or TIA with documented paroxysmal or persistent atrial fibrillation. A TIA will meet inclusion criteria as a sudden-onset focal neurological symptom or sign lasting at least 10 minutes but less than 24 hours with or without evidence of acute brain ischemia on diffusion weighted MRI imaging.
- Eligible symptoms INCLUDE hemiplegia or hemiparesis, monoplegia, or language disturbance other than isolated dysarthria.
- Symptoms that will NOT QUALIFY AS TIA INCLUDE transient monocular blindness in both eyes, dysarthria, vertigo,isolated sensory symptoms, confusion, memory loss, nonspecific complaints of dizziness, or syncope.
Exclusion
- Recent stroke (\< 1 month).
- Age \< 18 or \> 80 years; Ejection Fraction \< 25%• Presence of left atrial appendage thrombus on CT or echocardiography
- Previous empyema or thoracic surgery, preventing access to the pulmonary veins via thoracoscopy.
- Left Atrial Diameter \> 55mm.
- Contraindication to anticoagulation with Coumadin.
- Mitral insufficiency (\> 2+)
- • • Contraindications to MRI
- •Artificial heart valve prosthesis
- Aneurysm clips
- Implanted drug infusion device or pump
- Any type of neurotranstimulator
- Any type of bone growth stimulator
- Cochlear implants or inner ear prosthesis
- Any intravascular coils, filters, or stents
- Shrapnel or bullets
- Other metallic implants or devices specify which
- Permanently tattooed eyeliner
- Are you pregnant or suspect to be pregnant?
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01442181
Start Date
March 1 2010
End Date
November 1 2014
Last Update
July 23 2015
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610