Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation

NCT04172883 | Terminated Results

• 1 other identifier: MDT18039
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 11

Brief Summary

The MANDATE-AF study was designed to address evidence needs in India for device-based management of AF using AT/AF (Atrial Tachycardia/Atrial fibrillation) diagnostic features and therapies such as Reactive Atrial anti tachycardia Pacing (rATP) within Medtronic Cardiac Implantable Electronic Devices (CIED)and its impact on the time to persistent AF and progression of AT/AF.

Conditions

Cardiovascular Diseases

Keywords

Reactive ATP; device based Management of Atrial fibrilation; AF Management

Outcome Measures

Primary Outcomes (1)

• Incidence of 'Persistent AF' Over Time

  Probability of participants to encounter 'Persistant AF" was analyzed over time. This information is obtained using Kaplan-Meier method. The occurrence of Persistant AF has been studied over time by using Kaplan-Meier technique. Probabilities and their 95% confidence intervals have been obtained at baseline, 6 months, 12 months and 18 months. We are studying the occurrence of Persistant AF based on results obtained from the Kaplan-Meier method.

  up to 18 months

Secondary Outcomes (17)

• Incidence of All-cause Death Over Time

  up to 18 months

• Cardiovascular Hospitalization

  18 Months

• Annual Rate for All-cause Hospitalization

  18 months

• Incidence of AT/AF Burden ≥ 1day Overtime

  up to 18 months

• Incidence of AT/AF Burden ≥ 30 Days Overtime

  up to 18 months

Study Arms (2)

Control arm

NO INTERVENTION

The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the standard device setting or MINERVA setting ( control arm)

Treatment arm

ACTIVE COMPARATOR

The devices on the study are all commercially available and enabled with reactive ATP( rATP)feature, for the study both arms will have rATP switched on with one arm on the reduced sequence programming ( treatment arm)

Other: Treatment arm

Interventions

Treatment arm OTHER

All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF

Also known as: programming changes

Treatment arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (American heart Association/Heart rhythm Society) guidelines.
• Age \> 60 years;
• Stroke/TIA (Transient ischemic Attack);
• Diabetes;
• High Blood Pressure;
• Coronary artery disease;
• Cardiomyopathy;
• Pericardial inflammation;
• Prior heart attacks;
• Congestive heart failure;
• Structural heart disease (valve problems or congenital defects);
• Prior open-heart surgery;
• Untreated atrial flutter (another type of abnormal heart rhythm);
• Thyroid disease;
• Chronic lung disease;

You may not qualify if:

• Patients are not eligible to be enrolled in the study if any of the following criteria is met:
• 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;
• Subject is in permanent AF or persistent AF at the baseline visit:
• 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, the investigators will refer to the Cardiac Compass reports:
• 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)
• Participation in other studies which could potentially conflict with this study;
• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (11)

Care Institute of medical sciences and research

Ahmedabad, Gujarat, India

Location

Apollo Hospital , Bannerghatta

Bangalore, Karnataka, India

Location

Apollo BGS Hospital

Mysore, Karnataka, India

Location

Aster Medicity

Kochi, Kerala, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Fortis Escorts Heart Institute

New Delhi, National Capital Territory of Delhi, India

Location

Apollo Hospital

Bhubaneshwar, Odisha, India

Location

Fortis Escort Hospital

Mohali, Punjab, India

Location

Eternal Heart Care center and Research

Jaipur, Rajasthan, India

Location

Apollo Hospital

Chennai, Tamil Nadu, India

Location

AIG hospital

Hyderabad, Telangana, India

Location

Related Publications (4)

• Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. doi: 10.1016/s0002-9343(02)01236-6.

  PMID: 12401529 BACKGROUND

• Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370.

  PMID: 11343485 RESULT

• Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH; ESC Committee for Practice Guidelines. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Europace. 2010 Oct;12(10):1360-420. doi: 10.1093/europace/euq350. No abstract available.

  PMID: 20876603 RESULT

• Kannel WB, Wolf PA, Benjamin EJ, Levy D. Prevalence, incidence, prognosis, and predisposing conditions for atrial fibrillation: population-based estimates. Am J Cardiol. 1998 Oct 16;82(8A):2N-9N. doi: 10.1016/s0002-9149(98)00583-9.

  PMID: 9809895 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Limitations and Caveats

The study execution was severely impacted by the COVID-19 pandemic. Due to poor enrollment rates, low follow-up compliance (33.1% of scheduled visits missed), changes to the operating unit product portfolio, very few Reactive ATP enabled devices locally available, and changes to the local evidence strategy, the decision was taken to terminate the study in August 2021, with a total of 75 subjects enrolled (out of 758 planned). Data was primarily analyzed using descriptive statistics.

Results Point of Contact

• Title: Dr.Vinay Rajan, Clinical Research Manager
• Organization: India Medtronic Pvt Ltd

vinay.rajan@medtronic.com

+91-2248810700

Study Officials

• Shantanu Sarkar, PhD

  Medtronic, PLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient is unaware of which type of programming changes have been made ( whether it is the reduced sequence programming or the standard Minerva setting )
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: November 21, 2019
• Study Start: October 1, 2019
• Primary Completion: July 15, 2021
• Study Completion: July 28, 2021
• Last Updated: February 27, 2026
• Results First Posted: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (11)