Clinical trial NCT01442181: Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Official title: Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 invasive surgical procedure or the use of medications.

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

Eligibility criteria: 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?

Primary outcomes:
measure: Quality of Life RAND 36-Item Health Survey
timeFrame: Change in baseline, 3 month, and 6 month
Secondary outcomes:
Other outcomes:
measure: STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)
timeFrame: Change in baseline, 3 month, and 6 month
measure: STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)
timeFrame: Change in baseline, 3 month, and 6 month
measure: Montreal Cognitive Assessment (Moca)
timeFrame: Change in baseline, 3 month, and 6 month
measure: Directed Fluency; Cowa (Controlled Oral Word Association Test)
timeFrame: Change in baseline, 3 month, and 6 month
measure: Hopkins Verbal Learning Test Version A
timeFrame: Change in baseline, 3 month, and 6 month
measure: Stroop Color Test
timeFrame: Change in baseline, 3 month, and 6 month
measure: Wtar (Wechsler Test of Adult Reading) Word List
timeFrame: Baseline
measure: Stroop Word Test
timeFrame: Change in Baseline, 3 month, and 6 month
measure: Directed Fluency, Animals
timeFrame: Change in Baseline, 3 month, and 6 month
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Thomas Beaver, MD
role: PRINCIPAL_INVESTIGATOR
References: