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

NCT ID: NCT04172883

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-01-31

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.

Detailed Description

New generation Cardiac Implantable Electronic devices (CIED's)such as Pacemakers, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy (CRT) has diagnostic and treatment delivery features which helps in slowing the progression of Atrial Fibrillation. A Study conducted in Europe, called the MINERVA Trial, showed the efficacy of a feature within Medtronic CIED's called (rATP)™, in the termination of abnormal rhythms by pacing stimuli, and clinical benefit in reducing incidence of Atrial Fibrillation. However, there is dearth of local evidence of this within the Indian population and also a need to show that turning on rATP does not compromise on battery depletion.

The MANDATE-AF study is a prospective , Interventional , Randomized, single blind study aiming to show that a reduced sequence programming of this rATP therapy ,can improve device battery longevity and is as effective as the Minerva trial ATP programming when it comes to showing its impact on time to persistent AF and on the progression of AT/AF within the Indian population.

The study analyses patients implanted with a Medtronic cardiac implantable device with an atrial lead and equipped with atrial ATP therapies.

The patients will be randomized into two groups:

• an interventional arm including patients with a conservative atrial ATP therapies programming setting
• a control, arm including patients with the same atrial ATP therapies programming setting adopted in the Minerva Trial

Cardiovascular events will be collected prospectively for at least 24 months after enrollment. Physicians will be recommended to schedule in clinic follow-up visits every 6 months and remote follow-up visits every 3 months in between. Every patient will be followed for at least 24 months, until the last patient enrolled exits the study.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control arm

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment arm

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)

Group Type: ACTIVE_COMPARATOR

Treatment arm

Intervention Type: 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

Interventions

Treatment arm

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

Intervention Type: OTHER

Other Intervention Names

programming changes

Eligibility Criteria

Inclusion Criteria

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 (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;
• Sleep apnea;
• Excessive alcohol use;
• Serious illness or infection.

Exclusion Criteria

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:

1. 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:

2. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shantanu Sarkar, PhD

Role: STUDY_CHAIR

Medtronic, PLC

Locations

Care Institute of medical sciences and research

Ahmedabad, Gujarat, India

Apollo Hospital , Bannerghatta

Bangalore, Karnataka, India

Apollo BGS Hospital

Mysore, Karnataka, India

Aster Medicity

Kochi, Kerala, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Fortis Escorts Heart Institute

New Delhi, National Capital Territory of Delhi, India

Apollo Hospital

Bhubaneshwar, Odisha, India

Fortis Escort Hospital

Mohali, Punjab, India

Eternal Heart Care center and Research

Jaipur, Rajasthan, India

Apollo Hospital

Chennai, Tamil Nadu, India

AIG hospital

Hyderabad, Telangana, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 12401529 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11343485 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20876603 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9809895 (View on PubMed)

Other Identifiers

MDT18039

Identifier Type: -

Identifier Source: org_study_id