A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation Recurrence
• Intervention / Treatment: Device: CardiaCareTM RR2

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with CardiaCareTM RR2	Device: CardiaCareTM RR2; Treatment with CardiaCareTM RR2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Ziv HealthCare Ltd.
• Investigators: Principal Investigator: Avi Sabbag, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): January 2, 2022
• Study Completion (Actual): January 2, 2022

Study Registration Dates

• First Submitted: September 6, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: CAR-POC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No