BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
NCT ID: NCT05872776
Last Updated: 2024-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2023-02-16
2025-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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RR2 wearable home-care: active device
Real stimulation with RR2 neuromodulation device
Neuromodulation with RR2 device
non-invasive neuromodulation with RR2 device
RR2 wearable home-care: sham control device
Mock sham stimulation with RR2 neuromodulation device
Mock sham neuromodulation with sham RR2 device
Mock sham stimulation with RR2 device
Interventions
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Neuromodulation with RR2 device
non-invasive neuromodulation with RR2 device
Mock sham neuromodulation with sham RR2 device
Mock sham stimulation with RR2 device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Ziv HealthCare Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ehud Chorin, MD
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Souraski Medical Center, Department of Cardiology
Locations
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Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Clalit Health Services (HMO)
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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Yelena Kyef
Role: primary
Other Identifiers
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CAR-POC-02
Identifier Type: -
Identifier Source: org_study_id
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