BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Study Overview
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Brief Summary
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Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients

Detailed Description
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After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's. After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days. Overall patients will participate in the study for 14 weeks.

Official Title
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A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Neuromodulation with RR2 device
* Device: Mock sham neuromodulation with sham RR2 device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours) Ability and willingness to sign an informed consent form Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone Known symptomatic AF event over the recent 3 months Willing not to change the antiarrhythmic treatment Exclusion Criteria: Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit Known history or current diagnosis of atrial flutter An active myocardial infarction evident from ECG Recent stroke or myocardial infarction (<6 months) History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block Unilateral or bilateral vagotomy History of persistent AF with documented AF episodes of >7 days Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF) History of Impaired systolic function with EF<40 % or NY Class III or IV heart failure classification Dilatated left atria with a diameter > 50mm as evident by an echocardiogram Currently enrolled in another study Recurrent vaso-vagal syncopal episodes Pregnancy or breast feeding Pacemaker or CRTD or any implanted electrical stimulating device History of epilepsy or seizures Peripheral neuropathy or dermatological condition affecting the tested upper extremity area Unsuitable for participating in the study according to attending physician

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RR2 wearable home-care: active device<br>Real stimulation with RR2 neuromodulation device | Device: Neuromodulation with RR2 device<br>* non-invasive neuromodulation with RR2 device<br>|
| Sham Comparator: RR2 wearable home-care: sham control device<br>Mock sham stimulation with RR2 neuromodulation device | Device: Mock sham neuromodulation with sham RR2 device<br>* Mock sham stimulation with RR2 device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AF burden | Defined as % of time in AF, during screening period compared to end of treatment period. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF burden defined as the total number of AF events during screening period compared to end of treatment period. |  | 14 weeks | 
| AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period |  | 14 weeks | 
| Change from baseline compared to end of treatment period in Life quality & symptoms as assessed by AF AFEQT(from 0-poor to 100-great), EHRA Score (from I-no symptoms to IV-disabling symptoms) and SF36 questionnaires (form 0-worst to 100-best) |  | 14 weeks | 
| Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control |  | 14 weeks | 
| Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions |  | 14 weeks | 
| Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period |  | 14 weeks | 
| Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden |  | 14 weeks | 
| Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session |  | 14 weeks | 
| Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period |  | 14 weeks | 
| Safety- number of AE | number and severity of adverse event | 14 weeks | 
| Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree) |  | 14 weeks |