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

October 5, 2010
July 17, 2015
March 2010
November 2013   (final data collection date for primary outcome measure)
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.

Quality of life satisfaction between patients treated surgically or patients treated medically in stroke patients with atrial fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF with validated metrics.
Complete list of historical versions of study NCT01442181 on ClinicalTrials.gov Archive Site
Not Provided
Comparison of Adverse Events between surgery and medical management patients [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
Compare adverse events between surgery and medical management patients, recurrent stroke,TIAs, AF burden, repeat interventions, bleeding and surgical morbidity. Maintaining NSR and 6 months.
  • 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.
Not Provided
 
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Stroke
  • 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
  • Other: Medical therapy
    Patients are treated with rhythm and rate control medications.
    Other Name: Medical Management
  • 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.
    Intervention: Procedure: Minimally Invasive Surgery
  • Active Comparator: Medical Therapy
    Patients are treated with rhythm and rate control medications.
    Intervention: Other: Medical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
November 2014
November 2013   (final data collection date for primary outcome measure)

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?
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01442181
433-2009
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Thomas Beaver, MD University of Florida
University of Florida
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP