Trial Outcomes & Findings for Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation (NCT NCT01442181)

NCT ID: NCT01442181

Last Updated: 2015-07-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Change in baseline, 3 month, and 6 month
• Results posted on: 2015-07-23

Participant Flow

Participant milestones

Measure	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.	Medical Therapy Patients are treated with rhythm and rate control medications.
Overall Study STARTED	14	11
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	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.	Medical Therapy Patients are treated with rhythm and rate control medications.
Overall Study patient refused surgery	1	0
Overall Study no insurance for surgery	1	0
Overall Study low ejection factor	0	1
Overall Study Lost to Follow-up	1	1
Overall Study patient in an additional study	1	0
Overall Study atrial fibrillation not noted	0	1

Baseline Characteristics

Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

Baseline characteristics by cohort

Measure	Minimally Invasive Surgery n=14 Participants 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 n=11 Participants Patients are treated with rhythm and rate control medications.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	3 Participants n=4 Participants	8 Participants n=27 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	2 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	9 Participants n=4 Participants	16 Participants n=27 Participants
Region of Enrollment United States	14 participants n=93 Participants	11 participants n=4 Participants	25 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Quality of Life RAND 36-Item Health Survey Baseline-Energy/fatigue	33 units on a scale Standard Deviation 19.8	46.25 units on a scale Standard Deviation 25.4
Quality of Life RAND 36-Item Health Survey 3month-Energy/fatigue	49.5 units on a scale Standard Deviation 20.6	49.16 units on a scale Standard Deviation 23.1
Quality of Life RAND 36-Item Health Survey 6month-Energy/fatigue	55.5 units on a scale Standard Deviation 14.4	54.37 units on a scale Standard Deviation 22.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) Baseline	41.20 units on a scale Standard Deviation 9.76	37.5 units on a scale Standard Deviation 8.68
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) 3 month	35.7 units on a scale Standard Deviation 10.88	35.00 units on a scale Standard Deviation 14.05
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory) 6 month	35.67 units on a scale Standard Deviation 11.54	42.38 units on a scale Standard Deviation 9.86

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) 3 month	36.50 units on a scale Standard Deviation 11.65	34.88 units on a scale Standard Deviation 12.64
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) Baseline	38.20 units on a scale Standard Deviation 10.50	40.50 units on a scale Standard Deviation 10.77
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory) 6 month	35.00 units on a scale Standard Deviation 10.69	35.38 units on a scale Standard Deviation 8.40

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Montreal Cognitive Assessment (Moca) Baseline	25.89 units on a scale Standard Deviation 3.55	23.25 units on a scale Standard Deviation 6.92
Montreal Cognitive Assessment (Moca) 3 month	26.44 units on a scale Standard Deviation 2.35	24.86 units on a scale Standard Deviation 5.93
Montreal Cognitive Assessment (Moca) 6 month	25.33 units on a scale Standard Deviation 4.36	24.38 units on a scale Standard Deviation 5.73

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Directed Fluency; Cowa (Controlled Oral Word Association Test) COWA, baseline	39.70 words Standard Deviation 9.23	29.38 words Standard Deviation 14.34
Directed Fluency; Cowa (Controlled Oral Word Association Test) COWA, 3 month	44.33 words Standard Deviation 12.12	27.00 words Standard Deviation 11.12
Directed Fluency; Cowa (Controlled Oral Word Association Test) COWA, 6 month	41.40 words Standard Deviation 10.30	28.25 words Standard Deviation 11.27

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Hopkins Verbal Learning Test Version A HVLT Total_6 month	19.22 words Standard Deviation 8.21	16.50 words Standard Deviation 6.72
Hopkins Verbal Learning Test Version A HVLT 1_baseline	4.70 words Standard Deviation 2.06	4.38 words Standard Deviation 1.41
Hopkins Verbal Learning Test Version A HVLT 1_3 month	6.00 words Standard Deviation 1.41	4.14 words Standard Deviation 1.77
Hopkins Verbal Learning Test Version A HVLT 1_6 month	6.00 words Standard Deviation 2.55	4.13 words Standard Deviation 2.42
Hopkins Verbal Learning Test Version A HVLT 2_baseline	5.50 words Standard Deviation 2.80	5.88 words Standard Deviation 1.96
Hopkins Verbal Learning Test Version A HVLT 2_3 month	7.67 words Standard Deviation 2.50	5.14 words Standard Deviation 2.85
Hopkins Verbal Learning Test Version A HVLT 2_6 month	6.44 words Standard Deviation 3.00	5.75 words Standard Deviation 2.71
Hopkins Verbal Learning Test Version A HVLT 3_baseline	7.10 words Standard Deviation 3.00	6.13 words Standard Deviation 3.14
Hopkins Verbal Learning Test Version A HVLT 3_3 month	7.44 words Standard Deviation 3.40	6.29 words Standard Deviation 2.14
Hopkins Verbal Learning Test Version A HVLT 3_6 month	6.78 words Standard Deviation 2.99	6.63 words Standard Deviation 1.85
Hopkins Verbal Learning Test Version A HVLT Total_baseline	17.30 words Standard Deviation 7.02	16.38 words Standard Deviation 5.93
Hopkins Verbal Learning Test Version A HVLT Total_3 month	21.11 words Standard Deviation 6.94	15.57 words Standard Deviation 6.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=9 Participants 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 n=6 Participants Patients are treated with rhythm and rate control medications
Stroop Color Test Stroop color_baseline	57.89 colors Standard Deviation 13.32	53.33 colors Standard Deviation 8.36
Stroop Color Test Stroop color_3 month	58.14 colors Standard Deviation 16.41	53.50 colors Standard Deviation 4.51
Stroop Color Test Stroop color_6 month	50.00 colors Standard Deviation 9.06	47.60 colors Standard Deviation 19.11

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Wtar (Wechsler Test of Adult Reading) Word List	40.50 words Standard Deviation 9.40	32.50 words Standard Deviation 7.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=9 Participants 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 n=6 Participants Patients are treated with rhythm and rate control medications
Stroop Word Test Stroop word_Baseline	74.78 words Standard Deviation 16.74	75.33 words Standard Deviation 15.32
Stroop Word Test Stroop word_3 month	80.71 words Standard Deviation 12.16	75.75 words Standard Deviation 7.27
Stroop Word Test Stroop word_6 month	76.00 words Standard Deviation 8.00	66.60 words Standard Deviation 24.14

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Minimally Invasive Surgery n=10 Participants 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 n=8 Participants Patients are treated with rhythm and rate control medications
Directed Fluency, Animals Animals, 3 month	17.89 animals Standard Deviation 4.20	15.00 animals Standard Deviation 5.23
Directed Fluency, Animals Animals, 6 month	17.70 animals Standard Deviation 7.24	14.50 animals Standard Deviation 5.68
Directed Fluency, Animals Animals, baseline	18.10 animals Standard Deviation 6.35	15.75 animals Standard Deviation 5.65

Adverse Events

Minimally Invasive Surgery

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Medical Therapy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Minimally Invasive Surgery n=14 participants at risk 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 n=11 participants at risk Patients are treated with rhythm and rate control medications.
Cardiac disorders thrombus left appendage	7.1% 1/14 • Number of events 1 • For the duration of treatment, up to 6 months	0.00% 0/11 • For the duration of treatment, up to 6 months
Cardiac disorders extensive pericardial adhesions	7.1% 1/14 • Number of events 1 • For the duration of treatment, up to 6 months	0.00% 0/11 • For the duration of treatment, up to 6 months

Other adverse events

Measure	Minimally Invasive Surgery n=14 participants at risk 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 n=11 participants at risk Patients are treated with rhythm and rate control medications.
Nervous system disorders imbalance and moemory loss	7.1% 1/14 • Number of events 1 • For the duration of treatment, up to 6 months	9.1% 1/11 • Number of events 1 • For the duration of treatment, up to 6 months
Metabolism and nutrition disorders passed out	0.00% 0/14 • For the duration of treatment, up to 6 months	9.1% 1/11 • Number of events 1 • For the duration of treatment, up to 6 months
Cardiac disorders external cardioversion	21.4% 3/14 • Number of events 3 • For the duration of treatment, up to 6 months	0.00% 0/11 • For the duration of treatment, up to 6 months
Musculoskeletal and connective tissue disorders open wound	14.3% 2/14 • Number of events 3 • For the duration of treatment, up to 6 months	0.00% 0/11 • For the duration of treatment, up to 6 months
Cardiac disorders tachycardia	7.1% 1/14 • Number of events 1 • For the duration of treatment, up to 6 months	0.00% 0/11 • For the duration of treatment, up to 6 months

Additional Information

Dr. Thomas Beaver

UF Healthcare

Phone: 352-273-5503

Email: thomas.beaver@surgery.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place