Trial · NCT01442181
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
NCT01442181, Not applicable, Completed, University of Florida; results first posted 2015-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation. Trials, record NCT01442181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01442181
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
- NCT number
- NCT01442181
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 25 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Atrial Fibrillation, Stroke
- Interventions
- Minimally Invasive Surgery, Medical therapy
- First posted
- 2011-09-28
- Last updated
- 2015-07-23
- Results first posted
- 2015-07-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
| Other | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Quality of Life RAND 36-Item Health Survey | Change in baseline, 3 month, and 6 month | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Change in baseline, 3 month, and 6 month | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) | Change in baseline, 3 month, and 6 month | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Montreal Cognitive Assessment (Moca) | Change in baseline, 3 month, and 6 month | 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. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Directed Fluency; Cowa (Controlled Oral Word Association Test) | Change in baseline, 3 month, and 6 month | 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. | words | MEAN |
| OTHER_PRE_SPECIFIED | Hopkins Verbal Learning Test Version A | Change in baseline, 3 month, and 6 month | 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. | words | MEAN |
| OTHER_PRE_SPECIFIED | Stroop Color Test | Change in baseline, 3 month, and 6 month | 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. | colors | MEAN |
| OTHER_PRE_SPECIFIED | Wtar (Wechsler Test of Adult Reading) Word List | Baseline | 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. | words | MEAN |
| OTHER_PRE_SPECIFIED | Stroop Word Test | Change in Baseline, 3 month, and 6 month | 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. | words | MEAN |
| OTHER_PRE_SPECIFIED | Directed Fluency, Animals | Change in Baseline, 3 month, and 6 month | 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. | animals | MEAN |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Quality of Life RAND 36-Item Health Survey | Minimally Invasive Surgery | Baseline-Energy/fatigue | 33 | Standard Deviation 19.8 | units on a scale |
| Quality of Life RAND 36-Item Health Survey | Medical Therapy | Baseline-Energy/fatigue | 46.25 | Standard Deviation 25.4 | units on a scale |
| Quality of Life RAND 36-Item Health Survey | Minimally Invasive Surgery | 3month-Energy/fatigue | 49.5 | Standard Deviation 20.6 | units on a scale |
| Quality of Life RAND 36-Item Health Survey | Medical Therapy | 3month-Energy/fatigue | 49.16 | Standard Deviation 23.1 | units on a scale |
| Quality of Life RAND 36-Item Health Survey | Minimally Invasive Surgery | 6month-Energy/fatigue | 55.5 | Standard Deviation 14.4 | units on a scale |
| Quality of Life RAND 36-Item Health Survey | Medical Therapy | 6month-Energy/fatigue | 54.37 | Standard Deviation 22.1 | units on a scale |
| STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Minimally Invasive Surgery | Baseline | 41.20 | Standard Deviation 9.76 | units on a scale |
| STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Medical Therapy | Baseline | 37.5 | Standard Deviation 8.68 | units on a scale |
| STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Minimally Invasive Surgery | 3 month | 35.7 | Standard Deviation 10.88 | units on a scale |
| STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) | Medical Therapy | 3 month | 35.00 | Standard Deviation 14.05 | units on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Minimally Invasive Surgery | 14 | |
| Overall Study | STARTED | Medical Therapy | 11 | |
| Overall Study | COMPLETED | Minimally Invasive Surgery | 10 | |
| Overall Study | COMPLETED | Medical Therapy | 8 | |
| Overall Study | NOT COMPLETED | Minimally Invasive Surgery | 4 | |
| Overall Study | NOT COMPLETED | Medical Therapy | 3 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | imbalance and moemory loss | Nervous system disorders | Minimally Invasive Surgery | 1 | 14 | 1 |
| other | imbalance and moemory loss | Nervous system disorders | Medical Therapy | 1 | 11 | 1 |
| other | passed out | Metabolism and nutrition disorders | Minimally Invasive Surgery | 0 | 14 | 0 |
| other | passed out | Metabolism and nutrition disorders | Medical Therapy | 1 | 11 | 1 |
| other | external cardioversion | Cardiac disorders | Minimally Invasive Surgery | 3 | 14 | 3 |
| other | external cardioversion | Cardiac disorders | Medical Therapy | 0 | 11 | 0 |
| other | open wound | Musculoskeletal and connective tissue disorders | Minimally Invasive Surgery | 2 | 14 | 3 |
| other | open wound | Musculoskeletal and connective tissue disorders | Medical Therapy | 0 | 11 | 0 |
| other | tachycardia | Cardiac disorders | Minimally Invasive Surgery | 1 | 14 | 1 |
| other | tachycardia | Cardiac disorders | Medical Therapy | 0 | 11 | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Minimally Invasive Surgery | ||
| Total, all-cause mortality | Medical Therapy | ||
| Total, other adverse events | Minimally Invasive Surgery | 6 | 14 |
| Total, other adverse events | Medical Therapy | 2 | 11 |
| Total, serious adverse events | Minimally Invasive Surgery | 2 | 14 |
| Total, serious adverse events | Medical Therapy | 0 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Minimally Invasive Surgery vs Medical Therapy: serious adverse events |
Source Trial comparisons
Tests3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
| Verbal Fluency | Other outcome | ConductCognition |
| Verbal Learning | Other outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01442181
GET https://conductscience.org/api/trials/v1/NCT01442181/results?page=2