Health Condition 1: I480- Paroxysmal atrial fibrillation
Conditions
Interventions
Intervention1: Cardiacare RR2 Device: Real stimulation with neuromodulation device for 20 min sessions, 2-3 times per week for 26 weeks in conjunction to daily 2 min ECG measurements 2 times per day
C
Sponsors
Dr Reddys Laboratories Limited
JSS Medical Research Asia Pacific Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women of 18-85 years with mild to moderate ( 2. AF burden (% of time in AF) of more than 0.5% and less than 25% as evident by a continuous 14 days ECG recording at baseline 3. Paroxysmal AF subjects with a documented ECG event of AF ( 4. Willing and capable of providing informed consent. 5. Known symptomatic AF event over the recent 2 months. 6. Symptomatic AF despite stable dose of anti-arrhythmic drugs (at least 2 months) 7. Willing not to change the antiarrhythmic treatment. 8. Capable of participating in all the testing associated with this clinical investigation. 9. Consent for using effective methods of contraception during the entire study period. 10. Subjects able to comprehend and comply with study requirements and procedures
Exclusion criteria
Exclusion criteria: Patients will be excluded if they have any of the following: 1. Hemodynamic instability (systolic blood pressure 170 bpm at Baseline) during recruitment visit 2. Left ventricular dysfunction (Left ventricular ejection fraction 50mm) 3. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases) 4. Recent stroke or myocardial infarction ( 5. Severe heart failure (NYHA III or IV) 6. Known history or current diagnosis of atrial flutter. 7. An active myocardial infarction evident from ECG 8. Recurrent Vaso-vagal syncopal episodes 9. Unilateral or bilateral vagotomy 10. Sick sinus syndrome, 1st, 2nd or 3rd degree AV block, bifascicular block or prolonged (PR >300ms) 11. Pregnancy or breastfeeding 12. Peripheral neuropathy or dermatological condition of upper extremity 13. Pacemaker or CRTD or any implanted electrical stimulating device 14. History of epilepsy or seizure 15. Currently enrolled in any other clinical trial 16. Unsuitable for participation in the study as per Investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in AF burden compared to end of treatment wherein AF burden is defined as percentage of time in AF (time in AF divided by total time monitored) during the 2 weeks’ measurement period in the active group compared to sham.Timepoint: Baseline, End of treatment (26 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| The total number of AF events The total number of symptomatic AF events The longest symptomatic AF episode Change in quality of life & symptoms as assessed by AF AFEQT questionaries & SF36 questionaries (Vitality sub-scale in 36–Item Short Form Health Survey) Change in inflammatory biomarkers IL-6, TNF-a Number or proportion of patients with progression of AF from paroxysmal to persistent or permanent AF Number of AF episodes lasting 6 hours or longer in the treatment arm compared to the sham Change in an acute reduction of PAC Change in ATA/PAC burden Change in AHRE burden Number of cardioversion and/or ablation procedures performed during the study follow-up period Proportion of executed Vs. planned self-treatments delivered by each patient Patient satisfaction & preferences as assessed by usability questionnaire Number & severity of adverse event Timepoint: Baseline, End of treatment (26 weeks) Baseline, End of treatment (26 weeks) During 26 week period Baseline, End of treatment (26 weeks) Baseline (Week 2), Week 28 During 26 week period During 26 week period before & immediately after neuromodulation sessions Baseline (Week 2), week 28 Baseline (Week 2), week 28 Week 15, Week 26 During 26 week period Week 28 During 26 week period | — |
Countries
India
Contacts
Public ContactVelangini Reddy
Dr. Reddy’s Laboratories Limited
Outcome results
None listed