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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
non-invasive neuromodulation with RR2 device
Mock sham stimulation with RR2 device
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGClalit Health Services (HMO)
Tel Aviv, Israel
NOT_YET_RECRUITINGChange in AF burden
Defined as % of time in AF, during screening period compared to end of treatment period.
Time frame: 14 weeks
AF burden defined as the total number of AF events during screening period compared to end of treatment period.
Time frame: 14 weeks
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
Time frame: 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)
Time frame: 14 weeks
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
Time frame: 14 weeks
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
Time frame: 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
Time frame: 14 weeks
Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden
Time frame: 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
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Time frame: 14 weeks
Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period
Time frame: 14 weeks
Safety- number of AE
number and severity of adverse event
Time frame: 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)
Time frame: 14 weeks