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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Procedure: Minimally Invasive Surgery; Other: Medical therapy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: Minimally Invasive Maze Procedure
Active Comparator: Medical Therapy; Patients are treated with rhythm and rate control medications.	Other: Medical therapy; Patients are treated with rhythm and rate control medications.; Other Names: Medical Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.	Change in baseline, 3 month, and 6 month
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Scores range from 20 to 80, with higher scores correlating with greater anxiety.	Change in baseline, 3 month, and 6 month
Montreal Cognitive Assessment (Moca)	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The score is 0 - 30 point test with the higher the score the better cognitive function.	Change in baseline, 3 month, and 6 month
Directed Fluency; Cowa (Controlled Oral Word Association Test)	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many words as possible beginning with a letter, excluding proper nouns, for one minute and this procedure is repeated three times.	Change in baseline, 3 month, and 6 month
Hopkins Verbal Learning Test Version A	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). This test measures word recognition. 12 words are read to the subject and they have to repeat as many as they can recall. There are 4 trials, each with 12 total possible words.	Change in baseline, 3 month, and 6 month
Stroop Color Test	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop color test, and only 6 patients in the medical therapy group completed the stroop color test. In this test, subjects are asked to read a list of color words. 100 is the maximum amount of correct responses per trial.	Change in baseline, 3 month, and 6 month
Wtar (Wechsler Test of Adult Reading) Word List	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The WTAR is composed of 50 irregularly spelled words and takes approximately 10 minutes to complete. The examiner begins by presenting the first word card and prompting the patient for a single pronunciation of the word. This procedure continues through all 50 word cards and is discontinued if the patient provides 12 consecutive incorrect pronunciations. Each correct pronunciation is given a score of 1, with 50 as the maximum raw score.	Baseline
Stroop Word Test	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). Only 9 patients in the minimally invasive surgery arm completed the stroop word test, and only 6 patients in the medical therapy group completed the stroop word test. In this test, subjects are asked to read a list of words. 100 is the maximum amount of correct responses per trial.	Change in Baseline, 3 month, and 6 month
Directed Fluency, Animals	Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation). The participant is asked to name as many animals as possible beginning with a letter, for one minute.	Change in Baseline, 3 month, and 6 month

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Thomas Beaver, MD, University of Florida

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: September 27, 2011
• First Posted (Estimate): September 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 23, 2015
• Last Update Submitted That Met QC Criteria: July 17, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation
• Other Study ID Numbers: 433-2009