STALL

Condition: Atrial fibrillation

Eligibility

Key Inclusion Criteria:

  • 18-75 years old
  • Symptomatic paroxysmal atrial fibrillation unresponsive to conventional therapy
  • Left atrial size <50 mm by transthoracic echocardiography

Key Exclusion Criteria:

  • Patients without atrial fibrillation episodes during the monitoring period
  • Left ventricular ejection fraction <40%
  • Heart failure with functional classes III or IV
Study Name

Using Electrical Nerve Stimulation to Control Atrial Fibrillation (IRB no. 00000581)

Summary

This study focuses on individuals who have symptomatic paroxysmal atrial fibrillation (irregular heartbeat) that has not been successfully treated with medications. The purpose of the study is to determine whether sending mild electrical signals under the skin will improve symptoms of atrial fibrillation by controlling heart rate. Specifically, researchers will evaluate the investigational use of the Medtronic Vectris 1X8 compact trial screening Lead Kit for Spinal Cord stimulation and the Medtronic wireless external neurostimulator. These devices are approved by the U.S. Food Drug Administration (FDA) to treat various conditions but are not approved by the FDA for the treatment of symptomatic paroxysmal atrial fibrillation.

Participants will be randomly assigned to 1 of 2 study groups. One group will receive the treatment, and the other will not. The main procedures of the study include a minimally invasive procedure to have a "lead" placed under the skin in the left chest area. All subjects will receive the "lead" implantation regardless of which treatment group they are assigned to.

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