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

Ziv HealthCare

Status: Completed

Conditions: Atrial Fibrillation Recurrence

Treatments: Device: CardiaCareTM RR2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04580953

CAR-POC-01

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Treatment with CardiaCareTM RR2

Experimental group

Treatment:

Device: CardiaCareTM RR2