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

Atrial Fibrillation Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580953
• Other study ID #: CAR-POC-01
• Status: Completed
• Phase: N/A
• Start date: January 28, 2021
• Est. completion date: January 2, 2022

Study information

• Verified date: February 2022
• Source: Ziv HealthCare Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2, 2022
• Est. primary completion date: January 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrence
• Recurrence

Intervention

Device:
• CardiaCareTM RR2
Treatment with CardiaCareTM RR2

Locations

Country	Name	City	State
Israel	Sheba medical center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Ziv HealthCare Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Frequency of self-treatments during the treatment period	Number of self-treatments delivered by each patient throughout the 8-week period	8 weeks
Secondary	Number of analyzed ECG	Number of analyzed ECG tests by cloud software	8 weeks
Secondary	AF recurrence	Number of patients with symptomatic AF recurrence during the 8-week period	8 weeks
Secondary	AFEQT quality of life questionnaire	Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire	8 weeks
Secondary	Centric questionnaire	Patient centric questionnaire	8 weeks
Secondary	Unscheduled emergency department visits	Number of unscheduled emergency department visits due to atrial fibrillation	8 weeks
Secondary	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
Secondary	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
Secondary	Heart rate variability (HRV)	Difference in acute heart rate variability (HRV) parameters before and after treatments	8 weeks
Secondary	First AF event	Time from Baseline until first AF event	8 weeks
Secondary	AF burden	AF burden measured as number of registered AF episodes	8 weeks
Secondary	AF burden	AF burden measured as the longest AF episode	8 weeks