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

Primary Purpose

Atrial Fibrillation Recurrence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CardiaCareTM RR2
Sponsored by
Ziv HealthCare Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Atrial Fibrillation Recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Sheba medical center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with CardiaCareTM RR2

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 6, 2020
Last Updated
February 21, 2022
Sponsor
Ziv HealthCare Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04580953
Brief Title
A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
Official Title
A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 28, 2021 (Actual)
Primary Completion Date
January 2, 2022 (Actual)
Study Completion Date
January 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv HealthCare Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation Recurrence

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with CardiaCareTM RR2
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CardiaCareTM RR2
Intervention Description
Treatment with CardiaCareTM RR2
Primary Outcome Measure Information:
Title
Assessment of system ECG function by the Number of ECG checks successfully conducted with record sent, received and stored by the system.
Description
Number of ECG checks successfully conducted with record sent, received and stored by the system.
Time Frame
8 weeks
Title
Assessment of system Nerumodulation function by the Number of self-treatments successfully conducted with record sent, received and stored by the system.
Description
Number of self-treatments successfully conducted with record sent, received and stored by the system.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Frequency of self-treatments during the treatment period
Description
Number of self-treatments delivered by each patient throughout the 8-week period
Time Frame
8 weeks
Title
Number of analyzed ECG
Description
Number of analyzed ECG tests by cloud software
Time Frame
8 weeks
Title
AF recurrence
Description
Number of patients with symptomatic AF recurrence during the 8-week period
Time Frame
8 weeks
Title
AFEQT quality of life questionnaire
Description
Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire
Time Frame
8 weeks
Title
Centric questionnaire
Description
Patient centric questionnaire
Time Frame
8 weeks
Title
Unscheduled emergency department visits
Description
Number of unscheduled emergency department visits due to atrial fibrillation
Time Frame
8 weeks
Title
Number of patients with reduced premature atrial complexes (PAC's) and atrial runs
Description
Number of patients with reduced premature atrial complexes (PAC's) and atrial runs from Week 1 to Week 8
Time Frame
8 weeks
Title
Number of patients with acute reduction of PAC's 90 min
Description
Number of patients with acute reduction of PAC's 90 min after each neuromodulation session
Time Frame
8 weeks
Title
Heart rate variability (HRV)
Description
Difference in acute heart rate variability (HRV) parameters before and after treatments
Time Frame
8 weeks
Title
First AF event
Description
Time from Baseline until first AF event
Time Frame
8 weeks
Title
AF burden
Description
AF burden measured as number of registered AF episodes
Time Frame
8 weeks
Title
AF burden
Description
AF burden measured as the longest AF episode
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avi Sabbag, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Ramat Gan
Country
Israel

12. IPD Sharing Statement

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

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