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Completed

NCT Number: NCT01442181

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

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.

Other names: Minimally Invasive Maze Procedure

Medical therapy

Other

Patients are treated with rhythm and rate control medications.

Other names: Medical Management

Primary outcomes

  1. Quality of Life RAND 36-Item Health Survey

    Time frame: Change in baseline, 3 month, and 6 month

    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 outcomes

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

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  2. STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  3. Montreal Cognitive Assessment (Moca)

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  4. Directed Fluency; Cowa (Controlled Oral Word Association Test)

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  5. Hopkins Verbal Learning Test Version A

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  6. Stroop Color Test

    Time frame: Change in baseline, 3 month, and 6 month

    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.

  7. Wtar (Wechsler Test of Adult Reading) Word List

    Time frame: Baseline

    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.

  8. Stroop Word Test

    Time frame: Change in Baseline, 3 month, and 6 month

    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.

  9. Directed Fluency, Animals

    Time frame: Change in Baseline, 3 month, and 6 month

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Sep 28, 2011
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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