A Prospective Clinical Study Aimed to Assess the Technical Feasibility of RR2 Wearable Home Care Neuromodulation System
NCT ID: NCT04580953
Last Updated: 2022-02-22
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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COMPLETED
NA
11 participants
INTERVENTIONAL
2021-01-28
2022-01-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Treatment with CardiaCareTM RR2
CardiaCareTM RR2
Treatment with CardiaCareTM RR2
Interventions
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CardiaCareTM RR2
Treatment with CardiaCareTM RR2
Eligibility Criteria
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Inclusion Criteria
2. Symptoms related to AF with high probability
3. Recent conversion or cardioversion to normal sinus rhythm (NSR) as evident by a documented electrocardiograms (ECG)
4. Participants are able and willing to provide a signed informed consent
5. Participants are able and willing to use RR2 homecare device and wear an ECG patch or a Holter monitor for 24 hours.
Exclusion Criteria
2. An active myocardial infarction evident from ECG signs
3. Presence of pre-excitation syndrome
4. History of sick sinus syndrome
5. History of persistent AF with documented episodes of \>7 days
6. Heart failure, acute or chronic
7. Participants currently enrolled in another study
8. Recurrent vaso-vagal syncopal episodes
9. Pregnancy or breast feeding
10. Pacemaker or Cardiac resynchronization therapy defibrillator (CRT-D) or any implantable electrical stimulating device
11. History of epilepsy or seizures
12. Peripheral neuropathy affecting the tested upper extremity
13. Participants unsuitable for participating in the study according to attending physician
14. Know allergy to .. (all materials that are in contact with patient's skin)
18 Years
ALL
No
Sponsors
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Ziv HealthCare Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Avi Sabbag, MD
Role: PRINCIPAL_INVESTIGATOR
Sheba Medical Center
Locations
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Sheba medical center
Ramat Gan, , Israel
Countries
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Other Identifiers
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CAR-POC-01
Identifier Type: -
Identifier Source: org_study_id
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