Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

February 6, 2023 updated by: Cala Health, Inc.

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"). 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Wrist Device
Twice daily stimulation sessions during the 4-week treatment period
Device: Wrist Device
peripheral nerve stimulation via wrist-worn device
ACTIVE_COMPARATOR: Ear Device
Twice daily stimulation sessions during the 4-week treatment period
Device: Ear Device
peripheral nerve stimulation via ear-worn device
SHAM_COMPARATOR: Sham Device
Twice daily "stimulation" sessions during the 4-week treatment period
Device: Sham Device
Wrist-worn device that does not actually deliver stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Time Frame: 6 weeks
6 weeks
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Time Frame: 6 weeks
6 weeks
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Time Frame: 6 weeks
6 weeks
Number of AF episodes lasting >= 5.5 hours
Time Frame: 6 weeks
6 weeks
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Time Frame: 6 weeks
6 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: 6 weeks
6 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: 6 weeks
6 weeks
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of AF-related emergency visits
Time Frame: 6 weeks
6 weeks
Number of AF-related in-patient hospitalizations
Time Frame: 6 weeks
6 weeks
Number of cardioversion procedures
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cala Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFIB-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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