Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Neuromodulation with RR2 device

    Device

    non-invasive neuromodulation with RR2 device

  • Mock sham neuromodulation with sham RR2 device

    Device

    Mock sham stimulation with RR2 device

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: RR2 wearable home-care: active deviceActive comparator 1 intervention
Group B: RR2 wearable home-care: sham control deviceSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in AF burden

Defined as % of time in AF, during screening period compared to end of treatment period.

Time frame
14 weeks

Secondary outcomes

1

AF burden defined as the total number of AF events during screening period compared to end of treatment period.

Time frame
14 weeks
2

AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period

Time frame
14 weeks
3

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)

Time frame
14 weeks
4

Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control

Time frame
14 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ziv HealthCare Ltd.

Lead sponsor

Source ClinicalTrials.gov
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