Using Electrical Nerve Stimulation to Control Atrial Fibrillation (STALL-AF)
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|ClinicalTrials.gov Identifier: NCT04529941|
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : November 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Device Implant with Active Treatment Device: Device Implant without Active Treatment||Not Applicable|
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:
- Time-dependent reduction of AF burden
- Effects of ScNS on ventricular rate control during AF
- Reduction of SKNA
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model 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 comparing the 2 groups. The control group will have an option to cross over to the experimental group 3 weeks post-randomization to receive the stimulation. They will repeat the baseline visit, procedure visit and all follow-up visits post-procedure.
|Masking Description:||Subjects will not be aware whether the ScNS is turned on or off. However, after three weeks from the initial surgery, control subjects that decide to the second procedure will be aware of what group they were randomized to.|
|Official Title:||Using Electrical Nerve Stimulation to Control Atrial Fibrillation|
|Actual Study Start Date :||November 24, 2021|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
Experimental: Experimental Group
Will receive stimulation ScNS at 3.5mA output
Device: Device Implant with Active Treatment
ScNS at 3.5mA output for 2 weeks
Sham Comparator: Control Group
Does not receive therapy
Device: Device Implant without Active Treatment
No device output for 2 weeks
- AF Burden [ Time Frame: 2 weeks ]Lower AF burden from Baseline in the active treatment group than the control group
- Ventricular Rate Control [ Time Frame: 2 weeks ]Improved ventricular rate control during AF
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529941
|Contact: Peng-Sheng Chen, MD||310-423-6084||Chenp@cshs.org|
|Contact: Tracey S Early, BS, MAemail@example.com|
|United States, California|
|Los Angeles, California, United States, 90048|
|Contact: Jewel Reaso, BS 310-967-3854|
|Principal Investigator:||Peng-Sheng Chen, MD||Cedars-Sinai Medical Center|