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Paroxysmal AF subjects with a documented ECG event of AF will be recruited to the study To assess the efficacy of CardiaCareâ„¢ RR2 wearable home-care neuromodulation system in reducing AF burden and symptoms in Paroxysmal AF patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RR2 wearable home-care: active device | Active Comparator | Real stimulation with RR2 neuromodulation device |
|
| RR2 wearable home-care: sham control device | Sham Comparator | Mock sham stimulation with RR2 neuromodulation device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation with RR2 device | Device | non-invasive neuromodulation with RR2 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in AF burden | Defined as % of time in AF, during screening period compared to end of treatment period. | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adi Benari, MSc | Contact | +972-52-3863087 | adi.b@my-cardiacare.com | |
| Amos Ziv | Contact | +972524419884 | amos@my-cardiacare.com |
| Name | Affiliation | Role |
|---|---|---|
| Ehud Chorin, MD | Tel Aviv Souraski Medical Center, Department of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Mock sham neuromodulation with sham RR2 device | Device | Mock sham stimulation with RR2 device |
|
| 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 |
| 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 | 14 weeks |
| Proportion of patients with 20% change in ATA /PAC (Premature Atrial Contractions, measured 14 days continuance ECG) burden | 14 weeks |
| 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 | 14 weeks |
| Adherence: proportion of executed Vs. planned self-treatments delivered by each patient throughout the treatment period | 14 weeks |
| Safety- number of AE | number and severity of adverse event | 14 weeks |
| Patient satisfaction and preferences as assessed by patient centric (0-none to 10-worst) & usability questionnaires (1-strongly disagree to 5-strongly agree) | 14 weeks |
| Clalit Health Services (HMO) | Not yet recruiting | Tel Aviv | Israel |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |