Actively Recruiting
A Multi Center Randomized, Double Blinded, Sham Controlled Clinical Study to Determine the Efficacy of CardiaCare™ RR2 Home-care Neuromodulation System in Reducing Atrial Fibrillation Burden and Symptoms in Paroxysmal AF Patients
Led by Ziv HealthCare Ltd. · Updated on 2024-06-20
50
Participants Needed
2
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with paroxysmal atrial fibrillation (AF), a type of irregular heart rhythm, to see if the CardiaCare™ RR2 wearable home-care neuromodulation system can reduce AF episodes and symptoms. This is a randomized, double-blind, sham-controlled clinical study focused on evaluating the device's effect on AF burden and related quality of life factors. Participants will first undergo a 14-day screening period using a continuous ECG monitoring device. Eligible patients will then be randomly assigned to either an active treatment group using the RR2 neuromodulation device or a sham (placebo) treatment group. Over a 12-week treatment period, participants will perform self-administered neuromodulation sessions guided by a preset regimen and detection algorithm. They will also record two-minute ECGs twice daily and when experiencing symptoms using the RR2 system. After 10 weeks of treatment, patients will wear an ECG patch continuously for 14 more days. The entire study duration for each participant is 14 weeks. During this time, researchers will monitor changes in AF burden, quality of life, symptom scores, and arrhythmia episodes through various questionnaires and ECG measurements. They will also track adherence to treatment, patient satisfaction, and safety events. This comprehensive monitoring aims to assess the device's impact on AF frequency and symptoms while ensuring participant safety.
CONDITIONS
Brief Title
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 18 to 85 years with documented paroxysmal atrial fibrillation lasting less than 7 days
- AF burden between more than 0.5% and less than 25% based on 14 days continuous ECG at baseline
- Ability and willingness to sign informed consent
- Ability and willingness to use CardiaCare device, ECG chest patch, and have a smartphone available
- Known symptomatic AF event within the last 3 months
- Willingness to keep antiarrhythmic treatment unchanged during the study
You will not qualify if you...
- Hemodynamic instability with systolic blood pressure less than 100 mmHg or heart rate over 170 bpm at recruitment
- Known history or current diagnosis of atrial flutter
- Active myocardial infarction shown on ECG
- Recent stroke or myocardial infarction within 6 months
- History of sick sinus syndrome, advanced AV block, bifascicular block, or prolonged PR interval over 300 ms
- Previous unilateral or bilateral vagotomy
- History of persistent AF with episodes longer than 7 days
- Significant valvular heart disease or prosthetic valve
- Impaired systolic heart function with EF below 40% or advanced heart failure (NYHA class III or IV)
- Enlarged left atrium diameter over 50 mm by echocardiogram
- Current participation in another clinical study
- Recurrent vaso-vagal syncope episodes
- Pregnancy or breastfeeding
- Presence of pacemaker, CRTD, or implanted electrical stimulating device
- History of epilepsy or seizures
- Peripheral neuropathy or skin conditions affecting the upper arm tested area
- Considered unsuitable for study participation by the attending physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
Continuous ECG monitoring during this period
Duration - 12 weeks
Participants self-conduct neuromodulation sessions at home using the CardiaCare™ RR2 device following a treatment regimen and detection algorithm. They also measure daily 2-minute ECGs twice a day and when experiencing symptoms.
Daily ECG measurements twice a day and neuromodulation sessions as prompted throughout the treatment period
Duration - 14 days
Participants wear an ECG patch continuously for additional monitoring after 10 weeks of treatment.
Continuous ECG patch monitoring
Trial Site Locations
Total: 2 locations
1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Actively Recruiting
2
Clalit Health Services (HMO)
Tel Aviv, Israel
Not Yet Recruiting
Research Team
A
Adi Benari, MSc
A
Amos Ziv
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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