Actively Recruiting
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Led by Ziv HealthCare Ltd. · Updated on 2024-06-20
50
Participants Needed
2
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women ages 18-85 years with history of documented paroxysmal (<7 days) atrial fibrillation
- AF burden between more than 0.5% and less than 25% based on continuous 14 days ECG recording
- Ability and willingness to sign an informed consent form
- Ability and willingness to use CardiaCare home care device and ECG chest patch with an available smartphone
- Known symptomatic AF event within the recent 3 months
- Willingness to not change antiarrhythmic treatment during the study
You will not qualify if you...
- Hemodynamic instability with systolic blood pressure <100mmHg or heart rate >170 bpm at baseline
- Known history or current diagnosis of atrial flutter
- Active myocardial infarction evident from ECG
- Recent stroke or myocardial infarction within 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 episodes lasting >7 days
- Significant valvular disorder including prosthetic valve or hemodynamically relevant valvular diseases or valvular AF
- History of impaired systolic function with EF <40% or NYHA Class III or IV heart failure
- Dilated left atria with diameter >50mm on echocardiogram
- Currently enrolled in another study
- Recurrent vaso-vagal syncopal episodes
- Pregnancy or breastfeeding
- Presence of pacemaker, CRTD, or any implanted electrical stimulating device
- History of epilepsy or seizures
- Peripheral neuropathy or dermatological condition affecting the tested upper extremity
- Unsuitable for study participation as determined by attending physician
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Amos Ziv
CONTACT
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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