Atrial FibrillationNCT05653583
Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
A study testing Wrist Device and Ear Device in people with Atrial Fibrillation, run by Cala Health, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Wrist Device and Ear Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Mar 2023to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiac ablation within the last 6 months, or cardiac ablation planned within 8 weeks of Visit 1
- 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
- Prior or planned cardiac transplantation or cardiac surgery
- Cerebral ischemic event (stroke or transient ischemic attack) within the last 6 months
Show all 23Show fewer
- 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
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Mayo Clinic
Rochester, Minnesota, 55902
About this study
Official title: A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Wrist Device, Ear Device, Sham Device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wrist DeviceDevice
peripheral nerve stimulation via wrist-worn device
Ear DeviceDevice
peripheral nerve stimulation via ear-worn device
Sham DeviceDevice
Wrist-worn device that does not actually deliver stimulation
| Study group | Role | What they receive |
|---|---|---|
| Wrist Device | Active comparator | Twice daily stimulation sessions during the 4-week treatment period Receives: Device: Wrist Device |
| Ear Device | Active comparator | Twice daily stimulation sessions during the 4-week treatment period Receives: Device: Ear Device |
| Sham Device | Sham comparator | Twice daily "stimulation" sessions during the 4-week treatment period Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in AF during the treatment period compared to the run-in period (prior to treatment) for AF episodes >= 30 seconds duration
Measured: 8 weeks
Secondary outcomes (8)
Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Measured: 8 weeks
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Measured: 8 weeks
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Measured: 8 weeks
Number of AF episodes lasting >= 5.5 hours
Measured: 8 weeks
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Measured: 8 weeks
Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period
Measured: 8 weeks
Compliance to per-protocol therapy measured by the percentage of full and partial therapy sessions delivered relative to total sessions required per-protocol
Measured: 8 weeks
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start8 Mar 2023
- Primary completion24 Sep 2025
- Study completion15 Sep 2026
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cala Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653583
- Sponsor's protocol ID
- AFIB-01
- Status last verified
- Oct 2026
- First submitted
- 30 Nov 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05653583
- Acronym / sponsor ID
- AFIB-01
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cala Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wrist Device | Active comparator | Device: Wrist DeviceTwice daily stimulation sessions during the 4-week treatment period |
| Ear Device | Active comparator | Device: Ear DeviceTwice daily stimulation sessions during the 4-week treatment period |
| Sham Device | Sham comparator | Device: Sham DeviceTwice daily "stimulation" sessions during the 4-week treatment period |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (23 listed)
- Cardiac ablation within the last 6 months, or cardiac ablation planned within 8 weeks of Visit 1
- 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
- Prior or planned cardiac transplantation or cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wrist Deviceperipheral nerve stimulation via wrist-worn device | Device | Wrist Device |
| Ear Deviceperipheral nerve stimulation via ear-worn device | Device | Ear Device |
| Sham DeviceWrist-worn device that does not actually deliver stimulation | Device | Sham Device |
Primary outcome
Percentage of time spent in AF during the treatment period compared to the run-in period (prior to treatment) for AF episodes >= 30 seconds duration
Time frame: 8 weeks
8 secondary outcomes
Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Time frame: 8 weeks
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Time frame: 8 weeks
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Time frame: 8 weeks
Number of AF episodes lasting >= 5.5 hours
Time frame: 8 weeks
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Time frame: 8 weeks
Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period
Time frame: 8 weeks
Compliance to per-protocol therapy measured by the percentage of full and partial therapy sessions delivered relative to total sessions required per-protocol
Time frame: 8 weeks
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions
Time frame: 8 weeks
Results and safety
The study was stopped early (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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wrist Device and Ear Device in people with Atrial Fibrillation, run by Cala Health, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time spent in AF during the treatment period compared to the run-in period (prior to treatment) for AF episodes >= 30 seconds duration (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.