Atrial Fibrillation Management: CardiaCare™ Wearable Homecare Study ?

Phase 3

Conditions: Health Condition 1: I480- Paroxysmal atrial fibrillation

Registration Number: CTRI/2023/09/057605

Lead Sponsor: Dr Reddys Laboratories Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Other (Terminated)

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures