| CTRI Number |
CTRI/2023/09/057605 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
“Atrial Fibrillation Management: CardiaCare™ Wearable Homecare Study†|
|
Scientific Title of Study
|
A multicentre, prospective, randomized, double-blind, sham-controlled clinical study aimed to determine efficacy of CardiaCareâ„¢ RR2 (wearable home-care neuromodulation system) in reducing AF burden and symptoms in Paroxysmal AF patients. |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DRL-CAR-008, Version 2.0 dated 06-June-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C Narasimhan |
| Designation |
Consultant Cardiologist |
| Affiliation |
Asian Institute of Gastroenterology (AIG) |
| Address |
AIG Hospitals, First Floor, Beside Cluster E, Near Device Clinic Room No-03 Gachibowli, Mind Space Road
Hyderabad
TELANGANA
500032
India |
| Phone |
9848052409 |
| Fax |
|
| Email |
calambur1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhpreet Singh |
| Designation |
Medical Innovation Lead |
| Affiliation |
Dr. Reddy’s Laboratories Limited |
| Address |
Dr. Reddy’s Laboratories Limited, Integrated Product Development,
Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal -Malkajgiri
Hyderabad
TELANGANA
500090
India |
| Phone |
9953486799 |
| Fax |
|
| Email |
sukhpreetsingh@drreddys.com |
|
Details of Contact Person
Public Query
|
| Name |
Velangini Reddy |
| Designation |
Lead innovation PMO |
| Affiliation |
Dr. Reddy’s Laboratories Limited |
| Address |
8-2-337, Road Number 3, Banjara Hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9985388558 |
| Fax |
|
| Email |
velanginireddy@drreddys.com |
|
|
Source of Monetary or Material Support
|
| Dr. Reddy’s Laboratories Limited
Integrated Product Development,
Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal,Medchal -Malkajgiri District, Hyderabad – 500090, Telangana, India
|
|
|
Primary Sponsor
|
| Name |
Dr Reddys Laboratories Limited |
| Address |
8-2-337, Road No. 3, Banjara Hills, Hyderabad (India) - 500034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS Medical Research Asia Pacific Private Limited |
Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawaja Metro Station, Faridabad -121003, Haryana, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 13 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C Narasimhan |
AIG Hyderabad |
AIG Hospitals, First Floor, Beside Cluster E, Near Device Clinic Room No-03 Gachibowli, Mind Space Road, District – Hyderabad – 500032.
Hyderabad
TELANGANA |
9848052409
calambur1@gmail.com |
| Dr Gunjan Ghodeshwar |
All India Institute of Medical Science (AIIMS), Nagpur |
All India Institute of Medical Sciences Nagpur Department of Cardiology Room No - 124, 1st Floor, Plot No. 02 Sector 20, AIIMS Mihan, Nagpur Maharashtra- 441108
Nagpur
MAHARASHTRA |
9902594923
gunjan.ghodeshwar@gmail.com |
| Dr Prasant Kumar Sahoo |
Apollo Bhubaneshwar |
Clinical Research Office, Apollo Research & Innovations 05th Floor, Apollo Hospital, Bhubaneswar Plot No – 251, Sainik School Road,
Unit-15, Bhubaneswar-751005,
Odisha, India
Puri
ORISSA |
8093060049
sahoocardio@yahoo.co.in |
| Dr Aftab Khan |
Apollo Multispeciality Hospital, Kolkata |
Apollo Multispeciality Hospitals Limited, Department of Clinical Trials, Day-care Building, 6th Floor, 58 Canal Circular Road, Kolkata 700054
Kolkata
WEST BENGAL |
9831257844
cardiokhan@gmail.com |
| Dr Shekhar Kunal |
ESIC Medical College and Hospital Faridabad |
ESIC Medical College and Hospital, Faridabad Clinical Trial Unit, MRU (Multidisciplinary Research Unit), Basement, ESIC Medical College and Hospital, NH3, NIT, Faridabad, Haryana, 121001. India
Faridabad
HARYANA |
7678620444
shekhar.kunal09@gmail.com |
| Dr Rajpal Abhaichand |
G Kuppuswamynaidu Memorial Hospital Coimbatore |
G. Kuppuswamy Naidu
Memorial Hospital, Ground Floor, Room No 15, A Block Department of Cardiology P.O Box
6327, Netaji Road,
Pappanaickenpalayam, Coimbatore - 641037
Coimbatore
TAMIL NADU |
9994722322
abhai.cardio@gmail.com |
| Dr Pramod Kumar Pareek |
Jawahar Lal Nehru Medical College |
Clinical Research Department Ground Floor Jawahar Lal Nehru Medical College, KALA Bagh, Ajmer - 305001
Ajmer
RAJASTHAN |
9829290725
dr.pramodpareek@gmail.com |
| Dr B Hygriv Rao |
Krishna Institute of Medical Sciences (KIMS) Hospital |
1-8, 31/1 Block – 3, 3rd Floor, Wing A, Room No: 56 Minister Road, Krishna Nagar, Ramgopalpet, Secunderabad,Telangana - 500003
Hyderabad
TELANGANA |
9848052320
hygriv@hotmail.com |
| Dr Jabir Abdullakutty |
Lisie Hospital |
Department of Cardiovascular Clinical Research, 5th Floor, St. Antony’s Block, Lisie Hospital P B No. 3053, District Ernakulam Kochi, Kerala - 682018
Ernakulam
KERALA |
9447011773
drjabi@yahoo.co.in |
| Dr Awadhesh Kumar Sharma |
LPS Institute of Cardiology & Cardiac Surgery |
LPS Institute of Cardiology & Cardiac Surgery, Near -1st Floor Blood Bank, GSVM Medical College, Swaroop Nagar, Kanpur - 208002 U P India
Kanpur Nagar
UTTAR PRADESH |
9501958802
awakush@gmail.com |
| Dr Nagendra Chouhan |
Medanta the Medicity Hospital |
Medanta- The Medicity Hospital Department Heart Institute 3rd Floor Room No. 27 CH Baktawar Singh Rd, Medicity, Islampur Colony, Sector 38,
District Gurugram, Haryana 122001
Gurgaon
HARYANA |
9971382999
nagendra.chouhan@medanta.org |
| Dr Sandeep Bansal |
VMMC and Safdarjung Hospital |
Department of Cardiology VMMC and Safdarjung
Hospital, New Delhi-110029
South
DELHI |
9810543368
drbansal2000@yahoo.com |
| Dr Raghu Cherukupalli |
Yashoda Hospital |
Dept. of Clinical Research, First Floor, Aarogya Sri Block Yashoda Hospital, Behind Hari Hara Kala Bhavan, SP Road, Secunderabad - 500003 Telangana
Hyderabad
TELANGANA |
9848155650
raghu@drraghu.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 13 |
| Name of Committee |
Approval Status |
| AIG Hyderabad |
Approved |
| Apollo Bhubaneshwar |
Approved |
| Apollo Multispeciality Hospital, Kolkata |
Approved |
| ESIC Medical College and Hospital Faridabad |
Approved |
| Institution Ethics Committee Lisie Hospital, Kerala |
Approved |
| Institution Ethics Committee VMMC and SJH VMMC and SAFARJUNG HOSPITAL |
Approved |
| Institutional Ethics Committee for Clinical Trial |
Approved |
| Institutional Ethics Committee G. Kuppuswmay Naidu Memorial Hospital |
Approved |
| Jawahar Lal Nehru Medical College |
Approved |
| KIMS Ethics Committee, Secunderabad |
Approved |
| LPS Institute of Cardiology & Cardiac Surgery |
Approved |
| Medanta the Medicity Hospital |
Approved |
| Yashoda Academy of Medical Education and Research Yashoda Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I480||Paroxysmal atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Sham cardiacare device |
Mock sham stimulation 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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
Baseline, End of treatment (26 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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-α
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
|
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 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Available treatments of AF have limited effects: 50%
ablation failure rates at 5 years, 80% cardioversion failure rates at 1 year,
and limited efficacy and multiple drug side-effects. There is an unmet need for
adjuvant therapy to standard care in a home-care setting. The rationale for
this study is to evaluate clinical outcomes and collect data of the CardiaCareâ„¢
(the world’s first Non-Invasive Nerve Stimulation Digital Therapeutic for
Cardiovascular Care).
CardiaCare™ is the world’s first non-invasive
nerve stimulation digital therapeutic for cardiovascular care and the first
home-care therapy delivery and real time monitoring system for people with AF.
CardiaCareâ„¢ is a wrist-band with medical grade ECG but with non-invasive
neuromodulation (nerve stimulation) capabilities that mediate a cardiovascular
antiarrhythmic response that reduces atrial fibrillation burden. |