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

Completed

Phase N/A Results

Trial Description

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

Conditions

Interventions

  • Surgery Procedure
    Intervention Desc: small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.
    ARM 1: Kind: Experimental
    Label: Minimally Invasive Surgery
    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 2: Kind: Experimental
    Label: medically treated
    Description: patients are treated with rhythm and rate control medications
  • Medical therapy Drug
    Intervention Desc: Patients are treated with rhythm and rate control medications.
    ARM 1: Kind: Experimental
    Label: Minimally Invasive Surgery
    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 2: Kind: Experimental
    Label: medically treated
    Description: patients are treated with rhythm and rate control medications
    ARM 3: Kind: Experimental
    Label: Medical Therapy
    Description: patients are treated with rhythm and rate control medications
  • Minimally Invasive Surgery Procedure
    Other Names: Minimally Invasive Maze Procedure
    Intervention Desc: Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.
    ARM 1: Kind: Experimental
    Label: Minimally Invasive Surgery
    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 2: Kind: Experimental
    Label: Medical Therapy
    Description: patients are treated with rhythm and rate control medications

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment
  • Observation: Cohort
  • Perspective: Prospective

Outcomes

Type Measure Time Frame Safety Issue
Secondary Compare quality of life and patient satisfaction between minimally invasive surgical pulmonary vein isolation and optimal medical therapy. Six months No
Primary Quality of life satisfaction between patients treated surgically or patients treated medically in stroke patients with atrial fibrillation 6 months No
Secondary Comparison of Adverse Events between surgery and medical management patients Baseline up to 6 months Yes
Primary Quality of life satisfaction between patients treated surgically in stroke patients with atrial fibrillation 6 months No
Primary Quality of life satisfaction in stroke patients with atrial fibrillation treated medically. 6 months No
Secondary Comparison of Adverse Events between surgery management patients Baseline up to 6 months Yes
Secondary Comparison of Adverse Events between medical management patients Baseline up to 6 months Yes
Primary Quality of Life RAND 36-Item Health Survey Change in baseline, 3 month, and 6 month No

Sponsors