STALL

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.


Inclusion Criteria

  • 18 to 75 years of age
  • Symptomatic AF.
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Study Location(s)

Beverly : Jewel Reaso

More about this Clinical Trial

Full Title

Using Electrical Nerve Stimulation to Control Atrial Fibrillation

Details
Disease Type/Condition

Atrial fibrillation and flutter

Principal Investigator

Chen, Peng-Sheng

Co-Investigators

Alexander Tuchman, Ashkan Ehdaie, Michael Shehata, Michael Shehata, Robert Siegel, Tiffany Perry

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000581

ClinicalTrials.gov ID

NCT04529941

Key Eligibility
ClinicalTrials.gov

Contact
Name

Jewel Reaso

Phone
310-423-6252
Email
Jewel.Reaso@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Atrial fibrillation and flutter

Principal Investigator

Chen, Peng-Sheng

Age Group

Adult

Phase

N/A

IRB Number

IIT-CHEN-2020-SPARC3

ClinicalTrials.gov ID

NCT04529941

Key Eligibility
ClinicalTrials.gov

Contact
Name

Jewel Reaso

Phone
310-423-6252
Email
Jewel.Reaso@cshs.org
Want to join the study or
learn more?