Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation



Status:Completed
Conditions:Atrial Fibrillation, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:March 2010
End Date:November 2014

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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 invasive surgical procedure or the use of medications.

Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation

Inclusion Criteria:

- 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 Criteria:

- 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?
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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