Atrial Fibrillation, Stroke
Conditions
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.
Detailed description
Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation
Interventions
PROCEDUREMinimally 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.
OTHERMedical therapy
Patients are treated with rhythm and rate control medications.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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?
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life RAND 36-Item Health Survey | 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
| Measure | Time frame | Description |
|---|---|---|
| STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | 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. |
| Montreal Cognitive Assessment (Moca) | 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. |
| Directed Fluency; Cowa (Controlled Oral Word Association Test) | 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. |
| Hopkins Verbal Learning Test Version A | 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. |
| STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | 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. |
| Wtar (Wechsler Test of Adult Reading) Word List | 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. |
| Stroop Word Test | 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. |
| Directed Fluency, Animals | 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. |
| Stroop Color Test | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Medical Therapy Patients are treated with rhythm and rate control medications. | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | atrial fibrillation not noted | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | low ejection factor | 0 | 1 |
| Overall Study | no insurance for surgery | 1 | 0 |
| Overall Study | patient in an additional study | 1 | 0 |
| Overall Study | patient refused surgery | 1 | 0 |
Baseline characteristics
| Characteristic | Minimally Invasive Surgery | Medical Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 14 participants | 11 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 14 | 2 / 11 |
| serious Total, serious adverse events | 2 / 14 | 0 / 11 |
Outcome results
Primary
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Quality of Life RAND 36-Item Health Survey | Baseline-Energy/fatigue | 33 units on a scale | Standard Deviation 19.8 |
| Minimally Invasive Surgery | Quality of Life RAND 36-Item Health Survey | 3month-Energy/fatigue | 49.5 units on a scale | Standard Deviation 20.6 |
| Minimally Invasive Surgery | Quality of Life RAND 36-Item Health Survey | 6month-Energy/fatigue | 55.5 units on a scale | Standard Deviation 14.4 |
| Medical Therapy | Quality of Life RAND 36-Item Health Survey | Baseline-Energy/fatigue | 46.25 units on a scale | Standard Deviation 25.4 |
| Medical Therapy | Quality of Life RAND 36-Item Health Survey | 3month-Energy/fatigue | 49.16 units on a scale | Standard Deviation 23.1 |
| Medical Therapy | Quality of Life RAND 36-Item Health Survey | 6month-Energy/fatigue | 54.37 units on a scale | Standard Deviation 22.1 |
Comparison: Energy and fatigue 3 month vs 6 month in minimally invasive groupp-value: 0.03Wilcoxon (Mann-Whitney)
Comparison: Comparison of the fatigue and energy was done in baseline-3 month, and 6 month in each group. Minimally Invasive: baseline vs 3 monthp-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: Energy and fatigue in medical therapy group; baseline vs 3 monthp-value: 0.49Wilcoxon (Mann-Whitney)
Comparison: Energy and fatigue 3 month vs 6 monthp-value: 0.06Wilcoxon (Mann-Whitney)
Other Pre-specified
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.
Time frame: Change in Baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Directed Fluency, Animals | Animals, baseline | 18.10 animals | Standard Deviation 6.35 |
| Minimally Invasive Surgery | Directed Fluency, Animals | Animals, 3 month | 17.89 animals | Standard Deviation 4.2 |
| Minimally Invasive Surgery | Directed Fluency, Animals | Animals, 6 month | 17.70 animals | Standard Deviation 7.24 |
| Medical Therapy | Directed Fluency, Animals | Animals, baseline | 15.75 animals | Standard Deviation 5.65 |
| Medical Therapy | Directed Fluency, Animals | Animals, 3 month | 15.00 animals | Standard Deviation 5.23 |
| Medical Therapy | Directed Fluency, Animals | Animals, 6 month | 14.50 animals | Standard Deviation 5.68 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, baseline | 39.70 words | Standard Deviation 9.23 |
| Minimally Invasive Surgery | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, 3 month | 44.33 words | Standard Deviation 12.12 |
| Minimally Invasive Surgery | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, 6 month | 41.40 words | Standard Deviation 10.3 |
| Medical Therapy | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, baseline | 29.38 words | Standard Deviation 14.34 |
| Medical Therapy | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, 3 month | 27.00 words | Standard Deviation 11.12 |
| Medical Therapy | Directed Fluency; Cowa (Controlled Oral Word Association Test) | COWA, 6 month | 28.25 words | Standard Deviation 11.27 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT Total_baseline | 17.30 words | Standard Deviation 7.02 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT Total_3 month | 21.11 words | Standard Deviation 6.94 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 1_baseline | 4.70 words | Standard Deviation 2.06 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 1_3 month | 6.00 words | Standard Deviation 1.41 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 1_6 month | 6.00 words | Standard Deviation 2.55 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 2_baseline | 5.50 words | Standard Deviation 2.8 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 2_3 month | 7.67 words | Standard Deviation 2.5 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 2_6 month | 6.44 words | Standard Deviation 3 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 3_baseline | 7.10 words | Standard Deviation 3 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 3_3 month | 7.44 words | Standard Deviation 3.4 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT 3_6 month | 6.78 words | Standard Deviation 2.99 |
| Minimally Invasive Surgery | Hopkins Verbal Learning Test Version A | HVLT Total_6 month | 19.22 words | Standard Deviation 8.21 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 3_6 month | 6.63 words | Standard Deviation 1.85 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT Total_baseline | 16.38 words | Standard Deviation 5.93 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 2_3 month | 5.14 words | Standard Deviation 2.85 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT Total_3 month | 15.57 words | Standard Deviation 6.08 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 3_3 month | 6.29 words | Standard Deviation 2.14 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 1_baseline | 4.38 words | Standard Deviation 1.41 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 2_6 month | 5.75 words | Standard Deviation 2.71 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 1_3 month | 4.14 words | Standard Deviation 1.77 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT Total_6 month | 16.50 words | Standard Deviation 6.72 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 1_6 month | 4.13 words | Standard Deviation 2.42 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 3_baseline | 6.13 words | Standard Deviation 3.14 |
| Medical Therapy | Hopkins Verbal Learning Test Version A | HVLT 2_baseline | 5.88 words | Standard Deviation 1.96 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Montreal Cognitive Assessment (Moca) | Baseline | 25.89 units on a scale | Standard Deviation 3.55 |
| Minimally Invasive Surgery | Montreal Cognitive Assessment (Moca) | 3 month | 26.44 units on a scale | Standard Deviation 2.35 |
| Minimally Invasive Surgery | Montreal Cognitive Assessment (Moca) | 6 month | 25.33 units on a scale | Standard Deviation 4.36 |
| Medical Therapy | Montreal Cognitive Assessment (Moca) | Baseline | 23.25 units on a scale | Standard Deviation 6.92 |
| Medical Therapy | Montreal Cognitive Assessment (Moca) | 3 month | 24.86 units on a scale | Standard Deviation 5.93 |
| Medical Therapy | Montreal Cognitive Assessment (Moca) | 6 month | 24.38 units on a scale | Standard Deviation 5.73 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Baseline | 41.20 units on a scale | Standard Deviation 9.76 |
| Minimally Invasive Surgery | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | 3 month | 35.7 units on a scale | Standard Deviation 10.88 |
| Minimally Invasive Surgery | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | 6 month | 35.67 units on a scale | Standard Deviation 11.54 |
| Medical Therapy | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Baseline | 37.5 units on a scale | Standard Deviation 8.68 |
| Medical Therapy | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | 3 month | 35.00 units on a scale | Standard Deviation 14.05 |
| Medical Therapy | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | 6 month | 42.38 units on a scale | Standard Deviation 9.86 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | Baseline | 38.20 units on a scale | Standard Deviation 10.5 |
| Minimally Invasive Surgery | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | 3 month | 36.50 units on a scale | Standard Deviation 11.65 |
| Minimally Invasive Surgery | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | 6 month | 35.00 units on a scale | Standard Deviation 10.69 |
| Medical Therapy | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | Baseline | 40.50 units on a scale | Standard Deviation 10.77 |
| Medical Therapy | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | 3 month | 34.88 units on a scale | Standard Deviation 12.64 |
| Medical Therapy | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | 6 month | 35.38 units on a scale | Standard Deviation 8.4 |
Other Pre-specified
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.
Time frame: Change in baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Stroop Color Test | Stroop color_baseline | 57.89 colors | Standard Deviation 13.32 |
| Minimally Invasive Surgery | Stroop Color Test | Stroop color_3 month | 58.14 colors | Standard Deviation 16.41 |
| Minimally Invasive Surgery | Stroop Color Test | Stroop color_6 month | 50.00 colors | Standard Deviation 9.06 |
| Medical Therapy | Stroop Color Test | Stroop color_baseline | 53.33 colors | Standard Deviation 8.36 |
| Medical Therapy | Stroop Color Test | Stroop color_3 month | 53.50 colors | Standard Deviation 4.51 |
| Medical Therapy | Stroop Color Test | Stroop color_6 month | 47.60 colors | Standard Deviation 19.11 |
Other Pre-specified
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.
Time frame: Change in Baseline, 3 month, and 6 month
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minimally Invasive Surgery | Stroop Word Test | Stroop word_Baseline | 74.78 words | Standard Deviation 16.74 |
| Minimally Invasive Surgery | Stroop Word Test | Stroop word_3 month | 80.71 words | Standard Deviation 12.16 |
| Minimally Invasive Surgery | Stroop Word Test | Stroop word_6 month | 76.00 words | Standard Deviation 8 |
| Medical Therapy | Stroop Word Test | Stroop word_Baseline | 75.33 words | Standard Deviation 15.32 |
| Medical Therapy | Stroop Word Test | Stroop word_3 month | 75.75 words | Standard Deviation 7.27 |
| Medical Therapy | Stroop Word Test | Stroop word_6 month | 66.60 words | Standard Deviation 24.14 |
Other Pre-specified
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.
Time frame: Baseline
Population: Patients with ischemic stroke or transient ischemic attack (TIA) with documented paroxysmal or persistent atrial fibrillation were eligible for the study if they demonstrated the following symptoms: hemiplegia or hemiparesis, monoplegia, or language disturbance.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minimally Invasive Surgery | Wtar (Wechsler Test of Adult Reading) Word List | 40.50 words | Standard Deviation 9.4 |
| Medical Therapy | Wtar (Wechsler Test of Adult Reading) Word List | 32.50 words | Standard Deviation 7.75 |