A multicentre, prospective, randomized, double-blind, sham-controlled clinical study aimed to determine efficacy of CardiaCare™ RR2 (wearable home-care neuromodulation system) in reducing AF burden and symptoms in Paroxysmal AF patients. - NI

Dr Reddys Laboratories Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年6月24日

试验速览

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•1. Men and women of 18-85 years with mild to moderate ( <7 days) paroxysmal atrial fibrillation.
•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 ( <7 days from onset) will be recruited into the study from hospital out-patient settings or patient database.
•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

•Patients will be excluded if they have any of the following:
•1. Hemodynamic instability (systolic blood pressure <100mmHg or heart rate >170 bpm at Baseline) during recruitment visit
•2. Left ventricular dysfunction (Left ventricular ejection fraction <40%) and Left atrial dilatation ( >50mm)
•3. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
•4. Recent stroke or myocardial infarction ( <6 months)
•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

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