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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01442181
First received: October 5, 2010
Last updated: April 29, 2014
Last verified: April 2014

October 5, 2010
April 29, 2014
March 2010
November 2013   (final data collection date for primary outcome measure)
  • 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.
Quality of life satisfaction between patients treated surgically or patients treated medically 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.
Complete list of historical versions of study NCT01442181 on ClinicalTrials.gov Archive Site
  • 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.
Comparison of Adverse Events between surgery and 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.
Not Provided
Not Provided
 
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation
Minimally Invasive Surgical Treatment Versus Medical Management for Stroke Patients With Atrial Fibrillation

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Stroke
  • 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: 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.
    Interventions:
    • Procedure: Minimally Invasive Surgery
    • Other: Medical therapy
  • Active Comparator: Medical Therapy
    patients are treated with rhythm and rate control medications
    Interventions:
    • Procedure: Minimally Invasive Surgery
    • Other: Medical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
November 2014
November 2013   (final data collection date for primary outcome measure)

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?
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01442181
433-2009
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Thomas Beaver, MD University of Florida
University of Florida
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP