Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

Cala Health

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Wrist Device; Device: Ear Device; Device: Sham Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT05653583

AFIB-01

Details and patient eligibility

About

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"). Additionally, a wrist-worn monitoring device will be used for the measurement of heart rate (HR), heart rate variability (HRV), and other biomarkers ("Cardiac Measurement Device (CMD)"). Finally, subjects will track AF episode onset, duration, and symptom type in an AF diary.

Enrollment: 30 estimated patients

Sex: All

Ages: 22 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 22 years of age and less than 80 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 one symptomatic atrial fibrillation episodes per month over the last three months
• AF burden of at least 5%, as measured within the past 3 months, with no change in AF treatment since measurement
• Willing to stay on stable medications for the duration of the study
• Able and willing to use their smartphone to download the application associated with the Cardiac Measurement Device
• Competent and willing to provide written, informed consent to participate in the study

Exclusion criteria

• Prior cardiac ablation, or cardiac ablation planned within 6 weeks of Visit 1
• Cardioversion procedure performed within the last 12 weeks
• Valvular atrial fibrillation by transthoracic echocardiography
• Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
• Prior or planned cardiac transplantation or cardiac surgery
• 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)
• Left ventricular ejection fraction less than 35%
• Recurrent vaso-vagal syncopal episodes
• Unilateral or bilateral vagotomy
• Hemodynamic instability
• Structural heart damage
• 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
• Not currently on anticoagulants
• History of epilepsy or seizures
• 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
• Known allergy to any of the device materials that are in contact with prospective subject's skin
• 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
• Subjects unable to communicate with the Investigator and study staff
• Presence of any health condition that should preclude participation in this study, per the Investigator's opinion

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Wrist Device

Active Comparator group

Description:

Twice daily stimulation sessions during the 4-week treatment period

Treatment:

Device: Wrist Device

Ear Device

Active Comparator group

Description:

Twice daily stimulation sessions during the 4-week treatment period

Treatment:

Device: Ear Device

Sham Device

Sham Comparator group

Description:

Twice daily "stimulation" sessions during the 4-week treatment period

Treatment:

Device: Sham Device