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

Completed

Phase N/A Results

Update History

24 Oct '13
A location was updated in Gainesville.
New
The overall status was removed for University of Florida.
6 Sep '12
The eligibility criteria were updated.
New
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?
Old
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, weight greater than 280 lbs 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?
20 Mar '12
The Summary of Purpose was updated.
New
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.
Old
The hypothesis of this trial is to study stroke patients with atrial fibrillation comparing Minimally Invasive Surgical Pulmonary Vein Isolation (MISPVI) to optimal medical therapy (MED)to determine if MISPVI is superior to MED in improving quality of life and reducing adverse events including recurrent stroke.
The description was updated.
New
Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation
Old
None.
The eligibility criteria were updated.
New
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, weight greater than 280 lbs 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?
Old
Inclusion Criteria: - patients with a history of stroke and paroxysmal, persistent or permanent atrial fibrillation Exclusion Criteria: - Recent stroke (< 3 months) Age < 18 or > 80; ejection fraction < 40% Presence of left atrial appendage thrombus on CT or echocardiogram Previous empyema or thoracic surgery, weight > 280 lbs preventing access to the pulmonary veins via thoracoscopy Left atrial diameter > 55mm Contraindication to anticoagulation with coumadin Mitral insufficiency (>2+) Presence of ventricular arrhythmia requiring medication or AICD Contraindications to MRI