A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System

Study Overview
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Brief Summary
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RR2 is a medical, home-care, digital therapeutic, wearable device. Its main purpose is to deliver prescheduled, non-invasive, peripheral neuromodulation therapy, in conjunction with standard medical care, to relieve AF symptoms, recurrence and overall burden.

Official Title
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A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System

Conditions
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Atrial Fibrillation Recurrence

Intervention / Treatment
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* Device: CardiaCareTM RR2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged ≥18 with ECG documented and symptomatic recent onset atrial fibrillation (AF), lasting less than 48 hours Symptoms related to AF with high probability Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG) Participants are able and willing to provide a signed informed consent Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours. Exclusion Criteria: Hemodynamic instability (systolic blood pressure <100mmHg or heart rate >170 bmp) An active myocardial infarction evident from ECG signs Presence of pre-excitation syndrome History of sick sinus syndrome History of persistent AF with documented episodes of >7 days Heart failure, acute or chronic Participants currently enrolled in another study Recurrent vaso-vagal syncopal episodes Pregnancy or breast feeding Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device History of epilepsy or seizures Peripheral neuropathy affecting the tested upper extremity Participants unsuitable for participating in the study according to attending physician Know allergy to .. (all materials that are in contact with patient's skin)

Ages Eligible for Study
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Minimum Age: 18 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with CardiaCareTM RR2<br> | Device: CardiaCareTM RR2<br>* Treatment with CardiaCareTM RR2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system. | Number of ECG checks successfully conducted with record sent, received and stored by the system. | 8 weeks | 
| Assessment of system Nerumodulation function by the Number of self-treatments successfully conducted with record sent, received and stored by the system. | Number of self-treatments successfully conducted with record sent, received and stored by the system. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of self-treatments during the treatment period | Number of self-treatments delivered by each patient throughout the 8-week period | 8 weeks | 
| Number of analyzed ECG | Number of analyzed ECG tests by cloud software | 8 weeks | 
| AF recurrence | Number of patients with symptomatic AF recurrence during the 8-week period | 8 weeks | 
| AFEQT quality of life questionnaire | Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire | 8 weeks | 
| Centric questionnaire | Patient centric questionnaire | 8 weeks | 
| Unscheduled emergency department visits | Number of unscheduled emergency department visits due to atrial fibrillation | 8 weeks | 
| Number of patients with reduced premature atrial complexes (PAC's) and atrial runs | Number of patients with reduced premature atrial complexes (PAC's) and atrial runs from Week 1 to Week 8 | 8 weeks | 
| Number of patients with acute reduction of PAC's 90 min | Number of patients with acute reduction of PAC's 90 min after each neuromodulation session | 8 weeks | 
| Heart rate variability (HRV) | Difference in acute heart rate variability (HRV) parameters before and after treatments | 8 weeks | 
| First AF event | Time from Baseline until first AF event | 8 weeks | 
| AF burden | AF burden measured as number of registered AF episodes | 8 weeks | 
| AF burden | AF burden measured as the longest AF episode | 8 weeks |