BEAT AF - Braking Ectopic Atrial Trends In 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
1 other identifier
interventional
50
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2023
CompletedFirst Submitted
Initial submission to the registry
April 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJune 20, 2024
June 1, 2024
1.8 years
April 30, 2023
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in AF burden
Defined as % of time in AF, during screening period compared to end of treatment period.
14 weeks
Secondary Outcomes (11)
AF burden defined as the total number of AF events during screening period compared to end of treatment period.
14 weeks
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
14 weeks
Change from baseline compared to end of treatment period in Life quality & symptoms as assessed by AF AFEQT(from 0-poor to 100-great), EHRA Score (from I-no symptoms to IV-disabling symptoms) and SF36 questionnaires (form 0-worst to 100-best)
14 weeks
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
14 weeks
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
14 weeks
- +6 more secondary outcomes
Study Arms (2)
RR2 wearable home-care: active device
ACTIVE COMPARATORReal stimulation with RR2 neuromodulation device
RR2 wearable home-care: sham control device
SHAM COMPARATORMock sham stimulation with RR2 neuromodulation device
Interventions
non-invasive neuromodulation with RR2 device
Mock sham stimulation with RR2 device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Clalit Health Services (HMO)
Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ehud Chorin, MD
Tel Aviv Souraski Medical Center, Department of Cardiology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2023
First Posted
May 24, 2023
Study Start
February 16, 2023
Primary Completion
December 1, 2024
Study Completion
March 1, 2025
Last Updated
June 20, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share