NCT04580953

Completed

A Prospective Clinical Study Aimed to Assess the Technical F...

Ziv HealthCare Ltd.Source

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Other study identifiers

Sponsor study identifier

CAR-POC-01

Study Type

interventional

Actual enrollment (reported)

11

Locations

1 country

Sites

1

Timeline

Study Start

January 28, 2021

Actual (reported)

Primary Completion

January 2, 2022

Actual (reported)

Study Completion

January 2, 2022

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 11 participants
Study completion date: January 2, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
September 6, 2020
Actual (reported)
First Posted
October 9, 2020
Actual (reported)
Study Start
January 28, 2021
Actual (reported)
Primary Completion
January 2, 2022
Actual (reported)
Study Completion
January 2, 2022
Actual (reported)

Last Updated: February 22, 2022
Status Verified: February 2022
Last Update Submitted: February 21, 2022

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
+7 more secondary outcomes

Study Arms (1)

Treatment with CardiaCareTM RR2

EXPERIMENTAL

Device: CardiaCareTM RR2

Interventions

CardiaCareTM RR2Device

Treatment with CardiaCareTM RR2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Ziv HealthCare Ltd.
Industrylead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

Study Officials

Avi Sabbag, MD
Sheba Medical Center
PRINCIPAL INVESTIGATOR

Enrollment

11 participants (actual enrollment reported by the registry).

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

Actual (reported)

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)

Contact the study team to confirm eligibility.

Primary Completion

January 2, 2022

Actual (reported)

Study Completion

January 2, 2022

Actual (reported)

Last Updated

February 22, 2022

Record last verified: 2022-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04580953
Data provider: ClinicalTrials.gov
Source updated: 2022-02-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:16 UTC

Locations

IL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (12)

Study Arms (1)

Treatment with CardiaCareTM RR2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations