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Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wrist Device
Ear Device
Sham Device
Sponsored by
Cala Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

22 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mayo Clinic
  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Wrist Device

Ear Device

Sham Device

Arm Description

Twice daily stimulation sessions during the 4-week treatment period

Twice daily stimulation sessions during the 4-week treatment period

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Number of AF episodes lasting >= 5.5 hours
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Atrial Fibrillation Effect on Quality of Life (AFEQL) score at the end of the treatment period compared to end of the run-in period
Compliance to per-protocol therapy measured by the percentage of full and partial therapy sessions delivered relative to total sessions required per-protocol
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions

Full Information

First Posted
November 30, 2022
Last Updated
February 6, 2023
Sponsor
Cala Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05653583
Brief Title
Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Official Title
A Feasibility Study of Peripheral Nerve Stimulation Therapy for Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cala Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wrist Device
Arm Type
Active Comparator
Arm Description
Twice daily stimulation sessions during the 4-week treatment period
Arm Title
Ear Device
Arm Type
Active Comparator
Arm Description
Twice daily stimulation sessions during the 4-week treatment period
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Twice daily "stimulation" sessions during the 4-week treatment period
Intervention Type
Device
Intervention Name(s)
Wrist Device
Intervention Description
peripheral nerve stimulation via wrist-worn device
Intervention Type
Device
Intervention Name(s)
Ear Device
Intervention Description
peripheral nerve stimulation via ear-worn device
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Wrist-worn device that does not actually deliver stimulation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time to first recurrence of any AF (>= 30 seconds duration) during treatment period compared to run-in period
Time Frame
6 weeks
Title
Time to first recurrence of symptomatic AF during treatment period compared to run-in period
Time Frame
6 weeks
Title
Average AF episode duration during the treatment period compared to the run-in period (for episodes >= 30seconds duration)
Time Frame
6 weeks
Title
Number of AF episodes lasting >= 5.5 hours
Time Frame
6 weeks
Title
Average duration of ongoing AF episodes (>= 30 seconds duration) following the start of therapy sessions
Time Frame
6 weeks
Title
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
Title
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
Title
Compliance of daily therapy measured by the percentage of treatment days subjects performed full or partial therapy sessions
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Number of AF-related emergency visits
Time Frame
6 weeks
Title
Number of AF-related in-patient hospitalizations
Time Frame
6 weeks
Title
Number of cardioversion procedures
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahrose Aratia
Phone
6506515296
Email
shahrose@calahealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa Nishihama
Phone
6506515296
Email
melissa@calahealth.com
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Nelson, CNP
First Name & Middle Initial & Last Name & Degree
Abhishek Deshmukh, MBBS
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Elshazly, MD MBEE

12. IPD Sharing Statement

Learn more about this trial

Peripheral Nerve Stimulation Therapy for Atrial Fibrillation

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