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

This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01442181
First received: October 5, 2010
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Stroke
 Procedure: Minimally Invasive Surgery
Other: Medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Quality of life satisfaction between patients treated surgically in stroke patients with atrial fibrillation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF with validated metrics.

  • Quality of life satisfaction in stroke patients with atrial fibrillation treated medically. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare quality of life of patient satisfaction between the surgery and or the medication in stroke patients with AF (atrial fibrillation) with validated metrics.


Secondary Outcome Measures:
  • Comparison of Adverse Events between surgery management patients [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
    Compare adverse events between surgery and medical management patients, recurrent stroke,TIAs, AF burden, repeat interventions, bleeding and surgical morbidity. Maintaining NSR(normal sinus rhythm) and 6 months.

  • Comparison of Adverse Events between medical management patients [ Time Frame: Baseline up to 6 months ] [ Designated as safety issue: Yes ]
    Compare adverse events between surgery and medical management patients, recurrent stroke,TIAs, AF burden, repeat interventions, bleeding and surgical morbidity. Maintaining NSR and 6 months.


Estimated Enrollment: 30
Study Start Date: March 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Procedure: Minimally 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.
Other Name: Minimally Invasive Maze Procedure
Other: Medical therapy
patients are treated with rhythm and rate control medications
Other Name: Medical Management
Active Comparator: Medical Therapy
patients are treated with rhythm and rate control medications
 Procedure: Minimally 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.
Other Name: Minimally Invasive Maze Procedure
Other: Medical therapy
patients are treated with rhythm and rate control medications
Other Name: Medical Management

Detailed Description:

Must have had a stroke or transient ischemic attack (TIA) and have Atrial Fibrillation

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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?
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442181

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra Robertson, RN     352-273-5510     debra.robertson@surgery.ufl.edu    
Principal Investigator: Thomas Beaver, MD            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Thomas Beaver, MD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01442181     History of Changes
Obsolete Identifiers: NCT01413971
Other Study ID Numbers: 433-2009
Study First Received: October 5, 2010
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 22, 2013