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

NCT01442181 | Completed Results

• 1 other identifier: 433-2009
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (9)

• STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)

  Change in baseline, 3 month, and 6 month

• STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)

  Change in baseline, 3 month, and 6 month

• Montreal Cognitive Assessment (Moca)

  Change in baseline, 3 month, and 6 month

Study Arms (2)

Minimally Invasive Surgery

ACTIVE COMPARATOR

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

Medical Therapy

ACTIVE COMPARATOR

Patients are treated with rhythm and rate control medications.

Other: Medical therapy

Interventions

Minimally Invasive Surgery 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.

Also known as: Minimally Invasive Maze Procedure

Minimally Invasive Surgery

Medical therapy OTHER

Patients are treated with rhythm and rate control medications.

Also known as: Medical Management

Medical Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Stroke

Interventions

Minimally Invasive Surgical Procedures; Nutrition Therapy; Practice Management, Medical

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Therapeutics; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Dr. Thomas Beaver
• Organization: UF Healthcare

thomas.beaver@surgery.ufl.edu

352-273-5503

Study Officials

• Thomas Beaver, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: September 28, 2011
• Study Start: March 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: July 23, 2015
• Results First Posted: July 23, 2015

Record last verified: 2015-07

Locations

US (1)