Clinical trial NCT04172883: Management of Device Detected AT and Impact of Device Treatment Algorithms on Atrial Fibrillation
Official title: Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Reactive ATP
device based Management of Atrial fibrilation
AF Management
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Time to persistent AF
timeFrame: 42months
Secondary outcomes:
measure: All-cause death(at the end of 24 months)
timeFrame: 42months
measure: Number of Cardiovascular hospitalization
timeFrame: 42 Months
measure: Annual rate for all-cause hospitalization
timeFrame: 42 months
measure: Measure the AT/AF burden metrics across various time points
timeFrame: 42 months
measure: Evaluate number of successful and unsuccessful treated AT/AF episodes out of the detected episodes
timeFrame: 42 months
measure: Measure number of delivered therapies per episode
timeFrame: 42 months
measure: Evaluate the number of ATP sequences
timeFrame: 42 months
measure: Evaluate number of stroke, TIA (Transient ischemic Attack ) or other thromboembolic events
timeFrame: 42 months
measure: Percentage of patients treated with anticoagulation therapy
timeFrame: 42 months
measure: Measure the LA diameter size
timeFrame: 42 months
measure: Number of Pharmacological and electrical cardio versions reported
timeFrame: 42 months
measure: Evaluate the biventricular pacing percentage
timeFrame: 42 months
measure: Incidence of the composite endpoints like death or Cardiovascular Hospitalizations
timeFrame: 42months
measure: Incidence of persistent AF in patients with sick sinus syndrome
timeFrame: 42 months
measure: Efficacy of Atrial ATP therapies measured by number of successful termination of AF events
timeFrame: 42 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: New Delhi
country: India
facility: Fortis Escorts Heart Institute
state: Delhi
city: Ahmedabad
country: India
facility: Care Institute of medical sciences and research
state: Gujarat
city: Bangalore
country: India
facility: Apollo Hospital , Bannerghatta
state: Karnataka
city: Mysore
country: India
facility: Apollo BGS Hospital
state: Karnataka
city: Kochi
country: India
facility: Aster Medicity
state: Kerala
city: Bhubaneshwar
country: India
facility: Apollo Hospital
state: Odisha
city: Mohali
country: India
facility: Fortis Escort Hospital
state: Punjab
city: Jaipur
country: India
facility: Eternal Heart Care center and Research
state: Rajasthan
city: Chennai
country: India
facility: Apollo Hospital
state: Tamil Nadu
city: Hyderabad
country: India
facility: AIG hospital
state: Telengana
Study officials:
affiliation: Medtronic, PLC
name: Shantanu Sarkar, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.