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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01442181
First received: October 5, 2010
Last updated: July 17, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Stroke
Procedure: Minimally Invasive Surgery
Other: Medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Quality of Life RAND 36-Item Health Survey [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.

  • STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.

  • Montreal Cognitive Assessment (Moca) [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.

  • Directed Fluency; Cowa (Controlled Oral Word Association Test) [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.

  • Hopkins Verbal Learning Test Version A [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.

  • Stroop Color Test [ Time Frame: Change in baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]

    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.


  • Wtar (Wechsler Test of Adult Reading) Word List [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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.


  • Stroop Word Test [ Time Frame: Change in Baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]

    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.


  • Directed Fluency, Animals [ Time Frame: Change in Baseline, 3 month, and 6 month ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: March 2010
Study Completion Date: November 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Medical Management

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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?
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442181

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Thomas Beaver, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01442181     History of Changes
Obsolete Identifiers: NCT01413971
Other Study ID Numbers: 433-2009
Study First Received: October 5, 2010
Results First Received: February 24, 2015
Last Updated: July 17, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Arrhythmias, Cardiac
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2015