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

• Sponsor: Ziv HealthCare Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04580953
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Recurrence	Device: CardiaCareTM RR2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
• Actual Study Start Date: Jan 28, 2021
• Actual Primary Completion Date: Jan 2, 2022
• Actual Study Completion Date: Jan 2, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Frequency of self-treatments during the treatment period [8 weeks]

   Number of self-treatments delivered by each patient throughout the 8-week period

2. Number of analyzed ECG [8 weeks]

   Number of analyzed ECG tests by cloud software

3. AF recurrence [8 weeks]

   Number of patients with symptomatic AF recurrence during the 8-week period

4. AFEQT quality of life questionnaire [8 weeks]

   Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire

5. Centric questionnaire [8 weeks]

   Patient centric questionnaire

6. Unscheduled emergency department visits [8 weeks]

   Number of unscheduled emergency department visits due to atrial fibrillation

7. 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

8. 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

9. Heart rate variability (HRV) [8 weeks]

   Difference in acute heart rate variability (HRV) parameters before and after treatments

10. First AF event [8 weeks]

    Time from Baseline until first AF event

11. AF burden [8 weeks]

    AF burden measured as number of registered AF episodes

12. AF burden [8 weeks]

    AF burden measured as the longest AF episode

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sheba medical center	Ramat Gan		Israel

Sponsors and Collaborators

• Ziv HealthCare Ltd.

Investigators

• Principal Investigator: Avi Sabbag, MD, Sheba Medical Center, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ziv HealthCare Ltd.
• ClinicalTrials.gov Identifier: NCT04580953
• Other Study ID Numbers: CAR-POC-01
• First Posted: Oct 9, 2020
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Recurrence

Study Results

No Results Posted as of Feb 22, 2022