Using a wearable device to reduce symptoms of paroxysmal atrial fibrillation
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
NA · Ziv HealthCare Ltd. · NCT05872776
This study is testing if a new wearable device can help people with paroxysmal atrial fibrillation feel better by reducing their symptoms over 12 weeks.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Ziv HealthCare Ltd. (industry) |
| Locations | 2 sites (Tel Aviv and 1 other locations) |
| Trial ID | NCT05872776 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of the CardiaCare™ RR2 wearable home-care neuromodulation system in reducing the burden and symptoms of paroxysmal atrial fibrillation (AF). Participants will undergo a 14-day screening with continuous ECG monitoring before being randomized into either an active treatment group or a sham treatment group. Over a 12-week treatment period, patients will conduct self-administered neuromodulation sessions and perform daily ECG recordings. After 10 weeks, participants will wear an ECG patch continuously for an additional 14 days to monitor their condition.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18-85 with documented paroxysmal atrial fibrillation and a specific AF burden.
Not a fit: Patients with hemodynamic instability, recent myocardial infarction, or certain heart block conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency and severity of AF episodes for patients.
How similar studies have performed: While similar neuromodulation approaches have been explored, this specific application in paroxysmal AF is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Tel Aviv and 1 other locations
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (RECRUITING)
- Clalit Health Services (HMO) — Tel Aviv, Israel (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Ehud Chorin, MD — Tel Aviv Souraski Medical Center, Department of Cardiology
- Study coordinator: Adi Benari, MSc
- Email: adi.b@my-cardiacare.com
- Phone: +972-52-3863087
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Paroxysmal Atrial Fibrillation