NCT04529941

Using Electrical Nerve Stimulation to Control Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine if sending mild electrical signals just under your skin will improve atrial fibrillation symptoms by controlling your heart rate.

Detailed description

Patients will have a 1:1 randomization to receive subcutaneous electrical nerve stimulation (ScNS) to observe if the stimulation can reduce atrial fibrillation burden in patients with symptomatic atrial fibrillation (AF). All subjects will undergo the implant of a neurostimulator lead. The experimental group will receive stimulation and the control group will not receive stimulation. All subjects will complete the same follow up visits to compare the 2 groups. Primary Objective: To test the hypothesis that chronic subcutaneous nerve stimulation can reduce AF burden in patients with severe symptomatic AF unresponsive to conventional therapies The secondary objective: To test the hypotheses that the effect of ScNS on the following endpoints is different between the two randomization groups: 1. Time-dependent reduction of AF burden 2. Effects of ScNS on ventricular rate control during AF 3. Reduction of SKNA 4. Improvement of quality of life The study will enroll patients with symptomatic atrial fibrillation unresponsive to conventional therapy defined by not responding to at least 1 antiarrhythmic drug. The study will enroll 30 patients, including 15 men and 15 women between the 18 and 75 years old. There will be no sex/gender/racial/ethnic based exclusion. Patients will be enrolled from the Cedars Sinai Medical Center. The patients will undergo surgical implantation of an externalized lead under the skin on the chest wall. The wire is then connected to a neurostimulator. The experimental group (Group A) will receive ScNS (3.5mA) for two weeks. The sham group (Group B) will receive sham (0 mA) stimulation for two weeks. The AF burden will be assessed by a 7-day mobile cardiac telemetry device provided by Preventice. An additional mobile cardiac telemetry device, Bittium Faros, will also be worn at similar time points to monitor skin sympathetic nerve activity. An Apple watch will be used to collect additional information on the frequencies of AF between the Baseline Visit until the 3 Month Visit 7 Day Mobile Cardiac Telemetry is complete. After completion of the week 3 visit, the sham group (Group B) will be able to receive ScNS (3.5 mA) for two weeks. The AF burden will be assessed post-procedure by mobile cardiac telemetry by Preventice and Bittium Faros Study duration: 36 Months Subject duration: up to 5 months.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Device Implant with Active Treatment	ScNS at 3.5mA output for 2 weeks
DEVICE	Device Implant without Active Treatment	No device output for 2 weeks

Timeline

• Start date: 2021-11-24
• Primary completion: 2024-09-04
• Completion: 2024-09-25
• First posted: 2020-08-28
• Last updated: 2025-10-02
• Results posted: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study