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BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

Primary Purpose

Paroxysmal Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Neuromodulation with RR2 device
Mock sham neuromodulation with sham RR2 device
Sponsored by
Ziv HealthCare Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Peripheral neuropathy or dermatological condition affecting the tested upper extremity area Unsuitable for participating in the study according to attending physician

Sites / Locations

  • Tel Aviv Sourasky Medical CenterRecruiting
  • Clalit Health Services (HMO)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

RR2 wearable home-care: active device

RR2 wearable home-care: sham control device

Arm Description

Real stimulation with RR2 neuromodulation device

Mock sham stimulation with RR2 neuromodulation device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

AF burden defined as the total number of AF events during screening period compared to end of treatment period.
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
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)
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period
Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden
Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session
Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period
Safety- number of AE
number and severity of adverse event
Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree)

Full Information

First Posted
April 30, 2023
Last Updated
May 14, 2023
Sponsor
Ziv HealthCare Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05872776
Brief Title
BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv HealthCare Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
After screening for 14 days with a continuous ECG monitoring device, eligible patients will be randomized to either active treatment or a sham treatment groups. For a treatment period of 12 weeks, patients will be prompted to self-conduct neuromodulation sessions based on: a. predetermined treatment regimen plus b. a detection algorithm. In addition, participants will measure at home, daily 2 min ECG's with the RR2 system two times a day and when feeling symptoms suspected as AF/AT/SVT or PAC's. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RR2 wearable home-care: active device
Arm Type
Active Comparator
Arm Description
Real stimulation with RR2 neuromodulation device
Arm Title
RR2 wearable home-care: sham control device
Arm Type
Sham Comparator
Arm Description
Mock sham stimulation with RR2 neuromodulation device
Intervention Type
Device
Intervention Name(s)
Neuromodulation with RR2 device
Intervention Description
non-invasive neuromodulation with RR2 device
Intervention Type
Device
Intervention Name(s)
Mock sham neuromodulation with sham RR2 device
Intervention Description
Mock sham stimulation with RR2 device
Primary Outcome Measure Information:
Title
Change in AF burden
Description
Defined as % of time in AF, during screening period compared to end of treatment period.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
AF burden defined as the total number of AF events during screening period compared to end of treatment period.
Time Frame
14 weeks
Title
AF burden defined as the total number of symptomatic AF events during screening period compared to end of treatment period
Time Frame
14 weeks
Title
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
Title
Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham control
Time Frame
14 weeks
Title
Group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before and immediately after neuromodulation sessions
Time Frame
14 weeks
Title
Mean group change in ATA (Atrial Tachyarrhythmias, score form 0 to 6)/ PAC ( Premature Atrial Contractions, number of PACs in 2 minute ECG ) burden from Screening period to End of treatment period
Time Frame
14 weeks
Title
Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden
Time Frame
14 weeks
Title
Mean group change in acute reduction of PAC (number of PACs in 2 minute ECG) compared before to up to 1 hour after each neuromodulation session
Time Frame
14 weeks
Title
Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period
Time Frame
14 weeks
Title
Safety- number of AE
Description
number and severity of adverse event
Time Frame
14 weeks
Title
Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree)
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Peripheral neuropathy or dermatological condition affecting the tested upper extremity area Unsuitable for participating in the study according to attending physician
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheli Gonnen, MSc
Phone
+972-54-6448097
Email
chelig@rs-ness.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amos Ziv
Phone
+972524419884
Email
amos@my-cardiacare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehud Chorin, MD
Organizational Affiliation
Tel Aviv Souraski Medical Center, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehud Chorin, MD
Facility Name
Clalit Health Services (HMO)
City
Tel Aviv
Country
Israel
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yelena Kyef

12. IPD Sharing Statement

Plan to Share IPD
No

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BEAT AF - Braking Ectopic Atrial Trends In Atrial Fibrillation

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