Using Electrical Nerve Stimulation to Control Atrial Fibrillation

What is the Purpose of this Study?

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.


Eligibility

  • 18 to 75 years of age
  • Symptomatic Paroxysmal AF.
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Where can I participate?

Beverly : Anxhela Kote

More about this Clinical Trial

What is the full name of this clinical trial?

Using Electrical Nerve Stimulation to Control Atrial Fibrillation

Study Details
Disease Type/Condition

Atrial fibrillation and flutter

Principal Investigator

Chen, Peng-Sheng

Co-Investigators

Alexander Tuchman, Ashkan Ehdaie, Eugenio Cingolani, Michael Shehata, Robert Siegel, Tiffany Perry, Xunzhang Wang

Age Group

Adult

Phase

N/A

IRB Number

STUDY00000581

ClinicalTrials.gov ID

NCT04529941

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Anxhela Kote

Email
Anxhela.Kote@cshs.org
Study Detail
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

Anxhela Kote

Email
Anxhela.Kote@cshs.org