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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
11
Treatment with CardiaCareTM RR2
Sheba medical center
Ramat Gan, Israel
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.
Time frame: 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.
Time frame: 8 weeks
Frequency of self-treatments during the treatment period
Number of self-treatments delivered by each patient throughout the 8-week period
Time frame: 8 weeks
Number of analyzed ECG
Number of analyzed ECG tests by cloud software
Time frame: 8 weeks
AF recurrence
Number of patients with symptomatic AF recurrence during the 8-week period
Time frame: 8 weeks
AFEQT quality of life questionnaire
Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire
Time frame: 8 weeks
Centric questionnaire
Patient centric questionnaire
Time frame: 8 weeks
Unscheduled emergency department visits
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of unscheduled emergency department visits due to atrial fibrillation
Time frame: 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
Time frame: 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
Time frame: 8 weeks
Heart rate variability (HRV)
Difference in acute heart rate variability (HRV) parameters before and after treatments
Time frame: 8 weeks
First AF event
Time from Baseline until first AF event
Time frame: 8 weeks
AF burden
AF burden measured as number of registered AF episodes
Time frame: 8 weeks
AF burden
AF burden measured as the longest AF episode
Time frame: 8 weeks