Management of Device detected Atrial Tachyarrhythmia and Impact of Device treatment algorithms on Atrial Fibrillation in Indian population.
试验速览
- 阶段
- 4 期
- 状态
- Other
- 入组人数
- 758
- 试验地点
- 12
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
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; 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.
- •oAge > 60 years; oStroke/TIA; oDiabetes; oHigh Blood Pressure; oCoronary artery disease; oCardiomyopathy; oPericardial inflammation; oPrior heart attacks; oCongestive heart failure; oStructural heart disease (valve problems or congenital defects); oPrior open-heart surgery; oUntreated atrial flutter (another type of abnormal heart rhythm); oThyroid disease; oChronic lung disease; oSleep apnea; oExcessive alcohol use; oSerious 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: 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.
结局指标
主要结局
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
时间窗: 3.5 years
次要结局
- 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;