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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minimally Invasive Surgery
Medical therapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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?

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Minimally Invasive Surgery

Medical Therapy

Arm Description

Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.

Patients are treated with rhythm and rate control medications.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 5, 2010
Last Updated
July 17, 2015
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01442181
Brief Title
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Official Title
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Minimally Invasive Surgery
Arm Type
Active Comparator
Arm Description
Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
Arm Title
Medical Therapy
Arm Type
Active Comparator
Arm Description
Patients are treated with rhythm and rate control medications.
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Surgery
Other Intervention Name(s)
Minimally Invasive Maze Procedure
Intervention Description
Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.
Intervention Type
Other
Intervention Name(s)
Medical therapy
Other Intervention Name(s)
Medical Management
Intervention Description
Patients are treated with rhythm and rate control medications.
Primary Outcome Measure Information:
Title
Quality of Life RAND 36-Item Health Survey
Description
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
Other Pre-specified Outcome Measures:
Title
STAI-FormY-1 Questionnaire (State-Trait Anxiety Inventory)
Description
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
Title
STAI-Form-Y2 Questionnaire (State-Trait Anxiety Inventory)
Description
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
Title
Montreal Cognitive Assessment (Moca)
Description
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
Title
Directed Fluency; Cowa (Controlled Oral Word Association Test)
Description
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
Title
Hopkins Verbal Learning Test Version A
Description
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
Title
Stroop Color Test
Description
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
Title
Wtar (Wechsler Test of Adult Reading) Word List
Description
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
Title
Stroop Word Test
Description
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
Title
Directed Fluency, Animals
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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?
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Beaver, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

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

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