Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

NCT05653583 | Unknown FDA Device

• 1 other identifier: AFIB-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent in AF during the 4-week treatment period compared to the 2-week run-in period (prior to treatment) for AF episodes >= 30 seconds duration

  6 weeks

Secondary Outcomes (8)

• Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period

  6 weeks

• Time to first recurrence of symptomatic AF during treatment period compared to run-in period

  6 weeks

• Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)

  6 weeks

• Number of AF episodes lasting >= 5.5 hours

  6 weeks

• Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions

  6 weeks

Other Outcomes (3)

• Number of AF-related emergency visits

  6 weeks

• Number of AF-related in-patient hospitalizations

  6 weeks

• Number of cardioversion procedures

  6 weeks

Study Arms (3)

Wrist Device

ACTIVE COMPARATOR

Twice daily stimulation sessions during the 4-week treatment period

Device: Wrist Device

Ear Device

ACTIVE COMPARATOR

Twice daily stimulation sessions during the 4-week treatment period

Device: Ear Device

Sham Device

SHAM COMPARATOR

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

Device: Sham Device

Interventions

Wrist Device DEVICE

peripheral nerve stimulation via wrist-worn device

Wrist Device

Ear Device DEVICE

peripheral nerve stimulation via ear-worn device

Ear Device

Sham Device DEVICE

Wrist-worn device that does not actually deliver stimulation

Sham Device

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cala Health, Inc.: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ear Protective Devices

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Personal Protective Equipment; Protective Devices; Equipment and Supplies; Protective Clothing; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Shahrose Aratia

CONTACT

6506515296; shahrose@calahealth.com

Melissa Nishihama

CONTACT

6506515296; melissa@calahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 16, 2022
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (2)