Skip to main content
OpenTrials
Completed

NCT Number: NCT04580953

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheba medical center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

CardiaCareTM RR2

Device

Treatment with CardiaCareTM RR2

Primary outcomes

  1. Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system.

    Time frame: 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.

    Time frame: 8 weeks

    Number of self-treatments successfully conducted with record sent, received and stored by the system.

Secondary outcomes

  1. Frequency of self-treatments during the treatment period

    Time frame: 8 weeks

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

  2. Number of analyzed ECG

    Time frame: 8 weeks

    Number of analyzed ECG tests by cloud software

  3. AF recurrence

    Time frame: 8 weeks

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

  4. AFEQT quality of life questionnaire

    Time frame: 8 weeks

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

  5. Centric questionnaire

    Time frame: 8 weeks

    Patient centric questionnaire

  6. Unscheduled emergency department visits

    Time frame: 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

    Time frame: 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

    Time frame: 8 weeks

    Number of patients with acute reduction of PAC's 90 min after each neuromodulation session

  9. Heart rate variability (HRV)

    Time frame: 8 weeks

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

  10. First AF event

    Time frame: 8 weeks

    Time from Baseline until first AF event

  11. AF burden

    Time frame: 8 weeks

    AF burden measured as number of registered AF episodes

  12. AF burden

    Time frame: 8 weeks

    AF burden measured as the longest AF episode

Sponsors and collaborators

Lead sponsor

Ziv HealthCare Ltd.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 9, 2020
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.