Atrial Fibrillation RecurrenceNCT04580953
A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
A study testing CardiaCareTM RR2 in people with Atrial Fibrillation Recurrence, run by Ziv HealthCare Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation Recurrence
- What is being tested?
- CardiaCareTM RR2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Jan 2021to 2 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- CardiaCareTM RR2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardiaCareTM RR2Device
Treatment with CardiaCareTM RR2
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CardiaCareTM RR2 | Experimental | Not described Receives: Device: CardiaCareTM RR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (12)
Frequency of self-treatments during the treatment period
Number of self-treatments delivered by each patient throughout the 8-week period
Measured: 8 weeks
Number of analyzed ECG
Number of analyzed ECG tests by cloud software
Measured: 8 weeks
AF recurrence
Number of patients with symptomatic AF recurrence during the 8-week period
Measured: 8 weeks
AFEQT quality of life questionnaire
Presence of AF-related symptoms and rate of significant symptom relief as assessed by AFEQT questionnaire
Measured: 8 weeks
Centric questionnaire
Patient centric questionnaire
Measured: 8 weeks
Unscheduled emergency department visits
Number of unscheduled emergency department visits due to atrial fibrillation
Measured: 8 weeks
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
Measured: 8 weeks
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
Measured: 8 weeks
Heart rate variability (HRV)
Difference in acute heart rate variability (HRV) parameters before and after treatments
Measured: 8 weeks
First AF event
Time from Baseline until first AF event
Measured: 8 weeks
AF burden
AF burden measured as number of registered AF episodes
Measured: 8 weeks
AF burden
AF burden measured as the longest AF episode
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start28 Jan 2021
- Primary completion2 Jan 2022
- Study completion2 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziv HealthCare Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Avi Sabbag, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580953
- Sponsor's protocol ID
- CAR-POC-01
- Status last verified
- Feb 2022
- First submitted
- 6 Sep 2020
- Last updated
- 22 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
- ClinicalTrials.gov ID
- NCT04580953
- Acronym / sponsor ID
- CAR-POC-01
- Conditions
- Atrial Fibrillation Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ziv HealthCare Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 2 Jan 2022 (actual)
- Study completion
- 2 Jan 2022 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with CardiaCareTM RR2 | Experimental | Device: CardiaCareTM RR2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardiaCareTM RR2Treatment with CardiaCareTM RR2 | Device | Treatment with CardiaCareTM RR2 |
Primary outcome
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.
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.
12 secondary outcomes
Frequency of self-treatments during the treatment period
Time frame: 8 weeks
Number of analyzed ECG
Time frame: 8 weeks
AF recurrence
Time frame: 8 weeks
AFEQT quality of life questionnaire
Time frame: 8 weeks
Centric questionnaire
Time frame: 8 weeks
Unscheduled emergency department visits
Time frame: 8 weeks
Number of patients with reduced premature atrial complexes (PAC's) and atrial runs
Time frame: 8 weeks
Number of patients with acute reduction of PAC's 90 min
Time frame: 8 weeks
Heart rate variability (HRV)
Time frame: 8 weeks
First AF event
Time frame: 8 weeks
AF burden
Time frame: 8 weeks
AF burden
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Sabbag, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardiaCareTM RR2 in people with Atrial Fibrillation Recurrence, run by Ziv HealthCare Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.