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

Completed · Not applicable

Conditions studied: Atrial Fibrillation, Stroke

In brief

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.

Key facts

Study ID

NCT01442181

Run by

University of Florida

People needed

25

Starts

2010-03-01

Expected to finish

2014-11-01

Last updated by the study team

2015-07-23

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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?

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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