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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with CardiaCareTM RR2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CardiaCareTM RR2 | Device | Treatment with CardiaCareTM RR2 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avi Sabbag, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Ramat Gan | Israel |
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| 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 |