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

Not Applicable

Completed

• Conditions: Atrial Fibrillation Recurrence

• Registration Number: NCT04580953
• Lead Sponsor: Ziv HealthCare Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-09
• Study Start: 2021-01-28
• Primary Completion: 2022-01-02
• Study Completion: 2022-01-02
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-21
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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

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

Trial Locations

Locations (1)

Sheba medical center; 🇮🇱 Ramat Gan, Israel