Clinical trial NCT04580953: A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
Official title: A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation Recurrence
Lead sponsor: Ziv HealthCare Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system.
timeFrame: 8 weeks
measure: Assessment of system Nerumodulation function by the Number of self-treatments successfully conducted with record sent, received and stored by the system.
timeFrame: 8 weeks
Secondary outcomes:
measure: Frequency of self-treatments during the treatment period
timeFrame: 8 weeks
measure: Number of analyzed ECG
timeFrame: 8 weeks
measure: AF recurrence
timeFrame: 8 weeks
measure: AFEQT quality of life questionnaire
timeFrame: 8 weeks
measure: Centric questionnaire
timeFrame: 8 weeks
measure: Unscheduled emergency department visits
timeFrame: 8 weeks
measure: Number of patients with reduced premature atrial complexes (PAC's) and atrial runs
timeFrame: 8 weeks
measure: Number of patients with acute reduction of PAC's 90 min
timeFrame: 8 weeks
measure: Heart rate variability (HRV)
timeFrame: 8 weeks
measure: First AF event
timeFrame: 8 weeks
measure: AF burden
timeFrame: 8 weeks
measure: AF burden
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Avi Sabbag, MD
role: PRINCIPAL_INVESTIGATOR
References: