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

Outcomes

Type Measure Time Frame Safety Issue
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