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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Procedure: Minimally Invasive Surgery
* Other: Medical therapy


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Minimally Invasive Surgery<br>Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery. | Procedure: Minimally Invasive Surgery<br>* Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.<br>* Other names: Minimally Invasive Maze Procedure;|
| Active Comparator: Medical Therapy<br>Patients are treated with rhythm and rate control medications. | Other: Medical therapy<br>* Patients are treated with rhythm and rate control medications.<br>* Other names: Medical Management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life RAND 36-Item Health Survey | Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. Items in the same scale are averaged together to create the 8 scale scores which will have a 0 to 100 range. | Change in baseline, 3 month, and 6 month |