Management of Device Detected Atrial Tachyarrhythmia( AT) and Impact of Device Treatment Algorithms on Atrial Fibrillation (AF) in Indian Population
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 79
- 试验地点
- 12
- 主要终点
- Time to persistent AF
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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 )
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Age > 55 years;
- •Subject provides informed consent;
- •Subject is willing and able to comply with the study procedures;
- •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.
排除标准
- •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.
结局指标
主要结局
Time to persistent AF
时间窗: 42months
time to persistent AF (defined as more than 7 continuous days of AF) or permanent AF
次要结局
- All-cause death(at the end of 24 months)(42months)
- Annual rate for all-cause hospitalization(42 months)
- Number of Cardiovascular hospitalization(42 Months)
- Measure the AT/AF burden metrics across various time points(42 months)
- Evaluate number of successful and unsuccessful treated AT/AF episodes out of the detected episodes(42 months)
- Measure number of delivered therapies per episode(42 months)
- Evaluate the number of ATP sequences(42 months)
- Evaluate number of stroke, TIA (Transient ischemic Attack ) or other thromboembolic events(42 months)
- Percentage of patients treated with anticoagulation therapy(42 months)
- Measure the LA diameter size(42 months)
- Number of Pharmacological and electrical cardio versions reported(42 months)
- Evaluate the biventricular pacing percentage(42 months)
- Incidence of the composite endpoints like death or Cardiovascular Hospitalizations(42months)
- Incidence of persistent AF in patients with sick sinus syndrome(42 months)
- Efficacy of Atrial ATP therapies measured by number of successful termination of AF events(42 months)