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?
25 Feb '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, 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 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 (< 3 months). - Age < 18 or > 80 years; Ejection Fraction < 40%. - 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+) - Presence of ventricular arrhythmia requiring medication or AICD (automatic implantable cardiac defibrillator). - Contraindications to MRI - Cardiac (heart) pacemaker/defibrillator - 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?