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

University of Florida

Status: Completed

Conditions: Atrial Fibrillation; Stroke

Treatments: Other: Medical therapy; Procedure: Minimally Invasive Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01442181

433-2009

Details and patient eligibility

About

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.

Full description

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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?

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Minimally Invasive Surgery

Active Comparator group

Description:

Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.

Treatment:

Procedure: Minimally Invasive Surgery

Medical Therapy

Active Comparator group

Description:

Patients are treated with rhythm and rate control medications.

Treatment:

Other: Medical therapy