NCT05653583Terminated
Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Reason given: The Sponsor and Principal Investigator have mutually agreed to initiate study closure due to prolonged recruitment challenges that have prevented the trial from meeting its enrollment milestones within the projected study timeline.
Brief summary (registry, in English)
This is a three-arm, single-blinded, randomized, sham-controlled, nonsignificant risk study to assess the feasibility of reducing Atrial Fibrillation burden with peripheral nerve stimulation. The three arms include treatment with a wrist-worn neuromodulation ("wrist device"), treatment with an ear-worn neuromodulation device ("ear device") and sham stimulation with wrist-worn device that does not actually deliver stimulation ("sham device"). ECG patches will be worn on the chest to measure AF episode onset and duration ("ECG Patch"). Finally, subjects will track AF episode onset, duration, and symptom type in an AF diary.
- Status (registry)
- Terminated
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 30 Nov 2022
- Start date
- 8 Mar 2023
- Primary completion date
- 24 Sept 2025
- Lead sponsor
- Cala Health, Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05653583
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned cardiac transplantation or cardiac surgery
- Current participation, or previous participation within the last 30 days, in another interventional clinical trial that may confound the results of this study, unless otherwise approved by the Sponsor
Other illness
- Cardiac ablation within the last 6 months, or cardiac ablation planned within 8 weeks of Visit 1
- Cerebral ischemic event (stroke or transient ischemic attack) within the last 6 months
- Myocardial infarction within the last 6 months
- Heart failure (NYHA class III or IV)
- Structural heart damage
- History of epilepsy or seizures
- Known allergy to any of the device materials that are in contact with prospective subject's skin
- Presence of any health condition that should preclude participation in this study, per the Investigator's opinion
Lab values
- Left ventricular ejection fraction less than 35%
Other
- Cardioversion procedure performed within the last 12 weeks
- Valvular atrial fibrillation by transthoracic echocardiography
- Abnormal left atrial enlargement, as measured by left atrial anteroposterior diameter greater than 5.5 cm or left atrial volume index greater than 48 mL/m2
- Recurrent vaso-vagal syncopal episodes
- Unilateral or bilateral vagotomy
- Hemodynamic instability
- Implanted active electrical medical device, such as pacemaker, implantable loop recorders, defibrillator, or deep brain stimulator
- Implanted metal or electrical devices in the head or treated hand
- Peripheral neuropathy affecting the upper left extremity
- Pregnancy, anticipated pregnancy, or nursing during the study
- Unable or unwilling to comply fully with study procedures and followup, including atrial fibrillation diary requirements
- Subjects unable to communicate with the Investigator and study staff
Who the study is looking for
- At least 22 years of age and up to 85 years of age
- Diagnosed with paroxysmal atrial fibrillation, as documented on ECG, trans-telephonic monitoring (TTM), cardiac event monitoring, Holter monitoring, or implantable loop recording (episodes must be longer than 30 seconds to qualify)
- At least two symptomatic or asymptomatic atrial fibrillation episodes over the last month, or at least one symptomatic or asymptomatic atrial fibrillation episode in the last two weeks
- On anticoagulants if indicated by treatment guidelines
- Willing to stay on stable medications for the duration of the study
- Competent and willing to provide written, informed consent to participate in the study
Age in the registry: 22 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina | Charleston | United States | Unknown status |
| Mayo Clinic | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.