BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
ConditionParoxysmal Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorZiv HealthCare Ltd.
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Neuromodulation with RR2 device
- Mock sham neuromodulation with sham RR2 device
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov