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

NCT04580953 | Completed

• 1 other identifier: CAR-POC-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation Recurrence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Frequency of self-treatments during the treatment period

  8 weeks

• Number of analyzed ECG

  8 weeks

• AF recurrence

  8 weeks

• AFEQT quality of life questionnaire

  8 weeks

• Centric questionnaire

  8 weeks

Study Arms (1)

Treatment with CardiaCareTM RR2

EXPERIMENTAL

Device: CardiaCareTM RR2

Interventions

CardiaCareTM RR2 DEVICE

Treatment with CardiaCareTM RR2

Treatment with CardiaCareTM RR2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged ≥18 with ECG documented and symptomatic recent onset atrial fibrillation (AF), lasting less than 48 hours
• Symptoms related to AF with high probability
• Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG)
• Participants are able and willing to provide a signed informed consent
• Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours.

You may not qualify if:

• Hemodynamic instability (systolic blood pressure \<100mmHg or heart rate \>170 bmp)
• An active myocardial infarction evident from ECG signs
• Presence of pre-excitation syndrome
• History of sick sinus syndrome
• History of persistent AF with documented episodes of \>7 days
• Heart failure, acute or chronic
• Participants currently enrolled in another study
• Recurrent vaso-vagal syncopal episodes
• Pregnancy or breast feeding
• Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device
• History of epilepsy or seizures
• Peripheral neuropathy affecting the tested upper extremity
• Participants unsuitable for participating in the study according to attending physician
• Know allergy to .. (all materials that are in contact with patient's skin)

Sponsors & Collaborators

• Ziv HealthCare Ltd.: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

Location

Study Officials

• Avi Sabbag, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: October 9, 2020
• Study Start: January 28, 2021
• Primary Completion: January 2, 2022
• Study Completion: January 2, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

IL (1)