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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).




 
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