| CTRI Number |
CTRI/2019/07/020101 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
23/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
Management of Device detected Atrial Tachyarrhythmia ( fast beating heart) and Impact of Device treatment on Atrial Fibrillation in Indian population |
|
Scientific Title of Study
|
Management of Device detected Atrial Tachyarrhythmia and Impact of Device treatment algorithms on Atrial Fibrillation in Indian population. |
| Trial Acronym |
MANDATE AF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0, dated 26 Feb 2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai MAHARASHTRA 400093 India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person Scientific Query
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt Ltd |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai MAHARASHTRA 400093 India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
Details of Contact Person Public Query
|
| Name |
Vinay Rajan |
| Designation |
Clinical Research Manager |
| Affiliation |
India Medtronic Pvt. Ltd. |
| Address |
India Medtronic Pvt. Ltd.
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
Mumbai MAHARASHTRA 400093 India |
| Phone |
|
| Fax |
|
| Email |
vinay.rajan@medtronic.com |
|
|
Source of Monetary or Material Support
|
| India Medtronic Pvt Ltd
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093
|
|
|
Primary Sponsor
|
| Name |
India Medtronic Pvt Ltd |
| Address |
Solitaire Corporate Park, Bldg No. 12, 4th Floor
Andheri Ghatkopar Link Road, Andheri (e)
Mumbai, Maharashtra - 400093 |
| Type of Sponsor |
Other [Medical Device Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 15 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr AM Karthigesan |
Apollo Hospital |
21, Greams Lane, Off Greams Road,Chennai-600006, TamilNadu, India Chennai TAMIL NADU |
91428295505
drkarthigesan_am@apollohospitals.com |
| Dr Arun Srinivas |
Apollo Hospital |
Apollo BGS Hospital
Dept of Cardiology
Adichuchanagiri Road, Kuvempunagar,
Mysuru, Karnataka -570023, India
Mysore KARNATAKA |
8212566666
arunsrinivas18@gmail.com |
| Dr Prasant Kumar Sahoo |
Apollo Hospital |
plot no 251, Sainik School Rd,
Unit 15, Gajapati Nagar,
Bhubaneswar, Odisha 751005, India"
Baudh ORISSA |
91-8093060049
drprasant_s@apollohospitals.com |
| DrGirish B Navasundi |
Apollo Hospital |
Apollo Hospital,#154/11, Opposite IIM, Bannerghatta Road, Bangalore- 560076
Bangalore KARNATAKA |
91-80-26304050
navasundi@rediffmail.com |
| Dr C Narasimhan |
Asian Institute of Gastroenterology |
Survey No 136, Plot No 2/3/4/5, 1, Mindspace Rd, Gachibowli, Hyderabad, Telangana 500032 Hyderabad TELANGANA |
9966241100
calambur@hotmail.com |
| DrPraveen Sreekumar |
Aster Medcity |
Kuttisahib Road Cheranalloor, South Chittoor, Kochi, Kerala 682027 Ernakulam KERALA |
9995805278
praveen_sreekumar2004@yahoo.com |
| DrCNarasimhan |
Care Hospital |
#6-3-248/2, Road no-1, Banjara Hills,Hyderabad-500034, India
Hyderabad TELANGANA |
040-30418888
calambur@hotmail.com |
| Dr Ajay Naik |
Care Institute of Medical Sciences and Research |
Care Institute of Medical Sciences and Research
Nr. Shukan Mall,
Off. Science City Road, Sola,Ahmedabad,Gujarat-380060, India
Ahmadabad GUJARAT |
07930101166
ajay.naik@cims.me |
| DrJitender Singh Makkar |
Eternal Hospital, Unit of Eternal Heart Care Centre & Research Institute |
Eternal Hospital,
Unit of Eternal Heart Care Centre & Research Institute,
3A, Jagatpura Road, Near Jahawar Circle, Jaipur-302017, Rajasthan, India"
Jaipur RAJASTHAN |
911415174000
drjsm@hotmail.com |
| Dr Anil Saxena |
Fortis Escort Hospital |
Fortis Escorts Hospital,A-22,23,2nd Floor, RC Building, Residential Tower, Okhla Road, New Delhi-110025, India
New Delhi DELHI |
911147135138
anil.saxena@hotmail.com |
| DrRajat Sharma |
Fortis Hospital |
Sector-62,Sahibzada Ajit Singh Nagar
Mohali, Punjab- 160062 Rupnagar PUNJAB |
7087045070
cl.researchfhmoh17@fortishealthcare.com |
| DrLawrance Jesuraj |
Kovai Medical Center & Hospital |
99, Avanashi Road,Coimbatore-641014, India Coimbatore TAMIL NADU |
9659641414
drjesuraj@gmail.com |
| DrKartikeya Bhargava |
Medanta - The Medicity |
Medanta- The Medicity
Sector 38, Gurgaon, 122001
Haryana, India
Gurgaon HARYANA |
1244141414
Kartikeya.Bhargava@Medanta.org |
| DrYash Paul Sharma |
Post Graduate Institute of Medical Education & Research |
Madhya Marg, Sector 12, Chandigarh, 160012 Chandigarh CHANDIGARH |
9417167214
sharma.yashpaul@pgimer.edu.in |
| DrJPSSawhney |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital
Old Rajinder Nagar, Rajinder Nagar,New Delhi- 110060, India
New Delhi DELHI |
91-11-42251547
jpssawhney@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 15 |
| Name of Committee |
Approval Status |
| Ethics Committee of Care Institute of Medical Sciences. |
Approved |
| Eternal Heart Care Institutional Ethics Committee (EHCIE). |
Approved |
| Ethics Committee, Sir Ganga Ram Hospital |
Approved |
| Institutional Ethics commitee, Fortis Mohali |
Approved |
| Institutional Ethics Committee , KMCH |
Submittted/Under Review |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
| Institutional Ethics Committee Clinical Studies (IEC-CS) |
Approved |
| Institutional Ethics Committee Clinical Studies (IEC-CS) |
Approved |
| Institutional Ethics Committee Clinical Studies (IEC-CS) |
Approved |
| Institutional Ethics Committee Clinical Studies (IEC-CS) |
Approved |
| Institutional Ethics Committee of Fortis Escort Heart Institute (FEHI) |
Approved |
| Institutional Ethics committee, Aster Medicity |
Approved |
| Institutional Ethics Committee, CARE Hospital |
Approved |
| Institutional Ethics Committee, PGIMER |
Submittted/Under Review |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I481||Persistent atrial fibrillation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Reactive-ATP |
Reactive ATP (rATP) is a feature available in the implanted device for this group of pts . There is no set frequency with which it acts , its based on the identification of an event the feature will act to mitigate AF . There is no separate administration route, as its a feature within the device already implanted. The rATP feature help prevent persistent AF.
The duration of Therapy is per standard of care and will last min of 24months and 42 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject is implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled no longer than 18 months and at the minimum 6 weeks has passed since the implant;
2. Age > 55 years;
3. Subject provides informed consent;
4. Subject is willing and able to comply with the study procedures;
5. Subject has documented history of atrial fibrillation or atrial flutter, or one or more of the risk factors for developing AF as per AHA/HRS guidelines. [26].
o Age > 60 years;
o Stroke/TIA;
o Diabetes;
o High Blood Pressure;
o Coronary artery disease;
o Cardiomyopathy;
o Pericardial inflammation;
o Prior heart attacks;
o Congestive heart failure;
o Structural heart disease (valve problems or congenital defects);
o Prior open-heart surgery;
o Untreated atrial flutter (another type of abnormal heart rhythm);
o Thyroid disease;
o Chronic lung disease;
o Sleep apnea;
o Excessive alcohol use;
o Serious illness or infection.
|
|
| ExclusionCriteria |
| Details |
Patients are not eligible to be enrolled in the study if any of the following criteria is met:
1. Subject has been implanted with a Medtronic cardiac implantable device with an atrial lead equipped with atrial ATP therapies (rATP) enabled for more than 18 months;
2. Subject is in permanent AF or persistent AF at the baseline visit:
a. The definition of permanent AF will be based on the physicians’ decision that nothing further can be done to cardiovert the patient or, in historical cases, we will refer to the Cardiac Compass reports:
b. The definition of persistent AF at baseline will refer to the Cardiac Compass reports (>7 consecutive days in AF with the last day being the day of enrollment)
3. Participation in other studies which could potentially conflict with this study;
4.Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to persistent AF, defined as more than 7 consecutive days of AF, retrieved by using the device AT/AF diagnostics, or time to permanent AF. Time 0 for the time to event calculation is defined as the enrollment date or the first day in sinus rhythm after enrollment |
3.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the two atrial ATP Programming arms in terms of clinical endpoints reported below, all-cause death (at the end of 24 months);cardiovascular hospitalization (HF, AF or other), measured as time to first event and annual rate, Annual rate for all-cause hospitalization; AT/AF burden metrics, measured in terms of time to first event (daily burden ≥1 day, ≥2 days, ≥30 days) or the ratio between time in AT/AF and the observation period;
|
3.5 years |
|
|
Target Sample Size
|
Total Sample Size="758" Sample Size from India="758"
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 4 |
|
Date of First Enrollment (India)
|
15/07/2019 |
| 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="3" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
The Medtronic study team will collaborate to publish the results of the study in an appropriate/highest impact local ( Indian) and global publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia with a prevalence of 1–2% in the general population . The prevalence of AF increases with age and, in the elderly population, cardiovascular (CV) risk factors and co-morbidities such as hypertension, diabetes, congestive heart failure, coronary artery disease, valvular heart disease (VHD), and stroke are common . The global prevalence and cost of AF are expected to surge owing to factors such as economic growth, an ageing population, and increased prevalence of risk factors for AF in both Western countries and rapidly developing countries such as Brazil, China, India, and Indonesia . By 2050, the number of people with AF is projected to be 15 million in the United States , and a similar trend is projected for the European population too . For India, the United Nations Populations Fund has projected a 326% increase in the number of people aged between 60 and 80 years by the year 2050 (from the year 2000). A 700% increase is projected in the number of people above the age of 80 years . Though large-scale population-based studies on the prevalence of AF are not available in India, the recently published PANARM HF trial showed an AF incidence of 15% across a population of 2205 patients symptomatic for cardiac arrhythmias or HF, who were indicated for implantable device/radiofrequency ablationThe MANDATE AF Study is a prospective randomized study aiming to show that a reduced Atrial anti-tachycardia pacing sequence programming, is as effective as Minerva trial programming.
The purpose of this study is to show that a reduced ATP sequence programming is non-inferior to Minerva study ATP programming with respect to time to persistent AF among Indian patients with a Cardiac Implantable Electronic Device (CIED).
|