Paroxysmal Atrial FibrillationNCT05872776
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
A study testing Neuromodulation with RR2 device in people with Paroxysmal Atrial Fibrillation, run by Ziv HealthCare Ltd. at 2 sites in Israel.
Trial summary
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Neuromodulation with RR2 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesIsrael
- Study dates
- 16 Feb 2023to Mar 2025
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation
- AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)
- Ability and willingness to sign an informed consent form
- Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone
- Known symptomatic AF event over the recent 3 months
- Willing not to change the antiarrhythmic treatment
Who cannot join
- Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit
- Known history or current diagnosis of atrial flutter
- An active myocardial infarction evident from ECG
- Recent stroke or myocardial infarction (<6 months)
- History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
- Unilateral or bilateral vagotomy
Show all 17Show fewer
- History of persistent AF with documented AF episodes of >7 days
- Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases or valvular AF)
- History of Impaired systolic function with EF<40 % or NY Class III or IV heart failure classification
- Dilatated left atria with a diameter > 50mm as evident by an echocardiogram
- Currently enrolled in another study
- Recurrent vaso-vagal syncopal episodes
- Pregnancy or breast feeding
- Pacemaker or CRTD or any implanted electrical stimulating device
- History of epilepsy or seizures
- Peripheral neuropathy or dermatological condition affecting the tested upper extremity area
- Unsuitable for participating in the study according to attending physician
Trial locations and contacts
2 sites in 1 country.
Israel2 sites, 2 recruiting
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Ehud Chorin, MD
- Not yet recruiting
Clalit Health Services (HMO)
Tel Aviv
Yelena Kyef
About this study
Official title: A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients
Read the detailed description
After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's.
After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days.
Overall patients will participate in the study for 14 weeks.
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Neuromodulation with RR2 device, Mock sham neuromodulation with sham RR2 device
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromodulation with RR2 deviceDevice
non-invasive neuromodulation with RR2 device
Mock sham neuromodulation with sham RR2 deviceDevice
Mock sham stimulation with RR2 device
| Study group | Role | What they receive |
|---|---|---|
| RR2 wearable home-care: active device | Active comparator | Real stimulation with RR2 neuromodulation device Receives: Device: Neuromodulation with RR2 device |
| RR2 wearable home-care: sham control device | Sham comparator | Mock sham stimulation with RR2 neuromodulation device Receives: Device: Mock sham neuromodulation with sham RR2 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AF burden
Defined as % of time in AF, during screening period compared to end of treatment period.
Measured: 14 weeks
Secondary outcomes (11)
AF burden defined as the total number of AF events during screening period compared to end of treatment period.
Measured: 14 weeks
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
Measured: 14 weeks
Change from baseline compared to end of treatment period in Life quality & symptoms as assessed by AF AFEQT(from 0-poor to 100-great), EHRA Score (from I-no symptoms to IV-disabling symptoms) and SF36 questionnaires (form 0-worst to 100-best)
Measured: 14 weeks
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
Measured: 14 weeks
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
Measured: 14 weeks
Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period
Measured: 14 weeks
Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden
Measured: 14 weeks
Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session
Measured: 14 weeks
Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period
Measured: 14 weeks
Safety- number of AE
number and severity of adverse event
Measured: 14 weeks
Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree)
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start16 Feb 2023
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv HealthCare Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ehud Chorin, MD, Principal investigator, Tel Aviv Souraski Medical Center, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872776
- Sponsor's protocol ID
- CAR-POC-02
- Status last verified
- Jun 2024
- First submitted
- 30 Apr 2023
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Randomized, Double Blinded, Sham Controlled, Clinical Study Aimed to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients
- ClinicalTrials.gov ID
- NCT05872776
- Acronym / sponsor ID
- CAR-POC-02
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ziv HealthCare Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 May 2023 (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.
Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCare™ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients
Detailed description
After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's.
After 10 weeks of treatment patients will be requested to wear an ECG patch continuously for an additional period of 14 days.
Overall patients will participate in the study for 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RR2 wearable home-care: active device | Active comparator | Device: Neuromodulation with RR2 deviceReal stimulation with RR2 neuromodulation device |
| RR2 wearable home-care: sham control device | Sham comparator | Device: Mock sham neuromodulation with sham RR2 deviceMock sham stimulation with RR2 neuromodulation device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation
- AF Burden (% time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline (at minimum 168 hours)
- Ability and willingness to sign an informed consent form
- Ability and willingness to use CardiaCare home care device and ECG chest patch and has an available smart phone
- Known symptomatic AF event over the recent 3 months
Key exclusion criteria (17 listed)
- Hemodynamic instability (systolic blood pressure <100mmHg or heart rate>170 bpm at Baseline) during recruitment visit
- Known history or current diagnosis of atrial flutter
- An active myocardial infarction evident from ECG
- Recent stroke or myocardial infarction (<6 months)
- History of sick sinus syndrome 2nd or 3rd degree AV block, bifascicular block or prolonged (PR>300ms) 1st degree AV block
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 |
|---|---|---|
| Neuromodulation with RR2 devicenon-invasive neuromodulation with RR2 device | Device | RR2 wearable home-care: active device |
| Mock sham neuromodulation with sham RR2 deviceMock sham stimulation with RR2 device | Device | RR2 wearable home-care: sham control device |
Primary outcome
Change in AF burden
Time frame: 14 weeks
Defined as % of time in AF, during screening period compared to end of treatment period.
11 secondary outcomes
AF burden defined as the total number of AF events during screening period compared to end of treatment period.
Time frame: 14 weeks
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
Time frame: 14 weeks
Change from baseline compared to end of treatment period in Life quality & symptoms as assessed by AF AFEQT(from 0-poor to 100-great), EHRA Score (from I-no symptoms to IV-disabling symptoms) and SF36 questionnaires (form 0-worst to 100-best)
Time frame: 14 weeks
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
Time frame: 14 weeks
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
Time frame: 14 weeks
Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period
Time frame: 14 weeks
Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden
Time frame: 14 weeks
Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session
Time frame: 14 weeks
Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period
Time frame: 14 weeks
Safety- number of AE
Time frame: 14 weeks
Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree)
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Ehud Chorin, MD principal investigator
Tel Aviv Souraski Medical Center, Department of Cardiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation with RR2 device in people with Paroxysmal Atrial Fibrillation, run by Ziv HealthCare Ltd. at 2 sites 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adi Benari, MSc (+972-52-3863087, adi.b@my-cardiacare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AF burden (time frame: 14 weeks). 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 20 Jun 2024.