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

NCT ID: NCT01442181

Last Updated: 2015-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-11-30

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

Conditions

Atrial Fibrillation; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimally Invasive Surgery

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

Group Type: ACTIVE_COMPARATOR

Minimally Invasive Surgery

Intervention Type: PROCEDURE

Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.

Medical Therapy

Patients are treated with rhythm and rate control medications.

Group Type: ACTIVE_COMPARATOR

Medical therapy

Intervention Type: OTHER

Patients are treated with rhythm and rate control medications.

Interventions

Minimally Invasive Surgery

Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.

Intervention Type: PROCEDURE

Medical therapy

Patients are treated with rhythm and rate control medications.

Intervention Type: OTHER

Other Intervention Names

Minimally Invasive Maze Procedure; Medical Management

Eligibility Criteria

Inclusion Criteria

• Patients with a history of stroke and paroxysmal, persistent or permanent AF.
• 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?

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Beaver, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

433-2009

Identifier Type: -

Identifier Source: org_study_id

NCT01413971

Identifier Type: -

Identifier Source: nct_alias