Atrial Fibrillation Recurrence
Conditions
Brief summary
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.
Interventions
DEVICECardiaCareTM RR2
Treatment with CardiaCareTM RR2
Sponsors
Ziv HealthCare Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women aged ≥18 with ECG documented and symptomatic recent onset atrial fibrillation (AF), lasting less than 48 hours 2. Symptoms related to AF with high probability 3. Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG) 4. Participants are able and willing to provide a signed informed consent 5. Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours.
Exclusion criteria
1. Hemodynamic instability (systolic blood pressure \<100mmHg or heart rate \>170 bmp) 2. An active myocardial infarction evident from ECG signs 3. Presence of pre-excitation syndrome 4. History of sick sinus syndrome 5. History of persistent AF with documented episodes of \>7 days 6. Heart failure, acute or chronic 7. Participants currently enrolled in another study 8. Recurrent vaso-vagal syncopal episodes 9. Pregnancy or breast feeding 10. Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device 11. History of epilepsy or seizures 12. Peripheral neuropathy affecting the tested upper extremity 13. Participants unsuitable for participating in the study according to attending physician 14. Know allergy to .. (all materials that are in contact with patient's skin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system. | 8 weeks | Number of ECG checks successfully conducted with record sent, received and stored by the system. |
| Assessment of system Nerumodulation function by the Number of self-treatments successfully conducted with record sent, received and stored by the system. | 8 weeks | Number of self-treatments successfully conducted with record sent, received and stored by the system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF recurrence | 8 weeks | Number of patients with symptomatic AF recurrence during the 8-week period |
| AFEQT quality of life questionnaire | 8 weeks | Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire |
| Centric questionnaire | 8 weeks | Patient centric questionnaire |
| Unscheduled emergency department visits | 8 weeks | Number of unscheduled emergency department visits due to atrial fibrillation |
| Frequency of self-treatments during the treatment period | 8 weeks | Number of self-treatments delivered by each patient throughout the 8-week period |
| Number of patients with acute reduction of PAC's 90 min | 8 weeks | Number of patients with acute reduction of PAC's 90 min after each neuromodulation session |
| Heart rate variability (HRV) | 8 weeks | Difference in acute heart rate variability (HRV) parameters before and after treatments |
| First AF event | 8 weeks | Time from Baseline until first AF event |
| AF burden | 8 weeks | AF burden measured as number of registered AF episodes |
| Number of patients with reduced premature atrial complexes (PAC's) and atrial runs | 8 weeks | Number of patients with reduced premature atrial complexes (PAC's) and atrial runs from Week 1 to Week 8 |
| Number of analyzed ECG | 8 weeks | Number of analyzed ECG tests by cloud software |
Countries
Israel
Outcome results
None listed