Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
NCT ID: NCT05653583
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2023-03-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Wrist Device
Twice daily stimulation sessions during the 4-week treatment period
Wrist Device
peripheral nerve stimulation via wrist-worn device
Ear Device
Twice daily stimulation sessions during the 4-week treatment period
Ear Device
peripheral nerve stimulation via ear-worn device
Sham Device
Twice daily "stimulation" sessions during the 4-week treatment period
Sham Device
Wrist-worn device that does not actually deliver stimulation
Interventions
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Wrist Device
peripheral nerve stimulation via wrist-worn device
Ear Device
peripheral nerve stimulation via ear-worn device
Sham Device
Wrist-worn device that does not actually deliver stimulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
79 Years
ALL
No
Sponsors
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Cala Health, Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Rochester, Minnesota, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Colleen Nelson, CNP
Role: primary
Mohamed Elshazly, MD MBEE
Role: primary
Other Identifiers
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AFIB-01
Identifier Type: -
Identifier Source: org_study_id
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