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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally Invasive Surgery | Active Comparator | Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery. |
|
| Medical Therapy | Active Comparator | Patients are treated with rhythm and rate control medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Beaver, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Medical Therapy | Patients are treated with rhythm and rate control medications. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Medical Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in baseline, 3 month, and 6 month |
For the duration of treatment, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| thrombus left appendage | Cardiac disorders | Systematic Assessment | case was canceled on the OR table due to clot in left appendage |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| imbalance and moemory loss | Nervous system disorders | Systematic Assessment | Head MRI and head CT were done both normal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas Beaver | UF Healthcare | 352-273-5503 | thomas.beaver@surgery.ufl.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| D044623 | Nutrition Therapy |
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D013812 | Therapeutics |
| D020399 | Practice Management |
| D011364 | Professional Practice |
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|
| Medical therapy | Other | Patients are treated with rhythm and rate control medications. |
|
|
| 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 |
| low ejection factor |
|
| Lost to Follow-up |
|
| patient in an additional study |
|
| atrial fibrillation not noted |
|
Patients are treated with rhythm and rate control medications.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | Medical Therapy | Patients are treated with rhythm and rate control medications |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | words | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | words | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | colors | Change in baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | words | Baseline |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | words | Change in Baseline, 3 month, and 6 month |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | animals | Change in Baseline, 3 month, and 6 month |
|
|
|
| 2 |
| 14 |
| 6 |
| 14 |
| EG001 | Medical Therapy | Patients are treated with rhythm and rate control medications. | 0 | 11 | 2 | 11 |
|
| extensive pericardial adhesions | Cardiac disorders | Systematic Assessment | case was canceled due to extensive pericardial adhesions |
|
|
| passed out | Metabolism and nutrition disorders | Systematic Assessment | passed out at home was transported to ER was diagnosed with dehydration |
|
| external cardioversion | Cardiac disorders | Systematic Assessment | atrial fibrillation |
|
| open wound | Musculoskeletal and connective tissue disorders | Systematic Assessment | open wound incision sites, home health care with wet to dry packing |
|
| tachycardia | Cardiac disorders | Systematic Assessment | fast heart rate, medication change and patient monitored |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D009934 |
| Organization and Administration |
| D006298 | Health Services Administration |
| 6 month |
|
| 6 month |
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| 6 month |
|
| COWA, 6 month |
|
| HVLT 1_6 month |
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| HVLT 2_baseline |
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| HVLT 2_3 month |
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| HVLT 2_6 month |
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| HVLT 3_baseline |
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| HVLT 3_3 month |
|
| HVLT 3_6 month |
|
| HVLT Total_baseline |
|
| HVLT Total_3 month |
|
| HVLT Total_6 month |
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| Stroop color_6 month |
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| Stroop word_6 month |
|
| Animals, 6 month |
|