MINERVA: MINimizE Right Ventricular Pacing to Prevent Atrial Fibrillation and Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,300
- 试验地点
- 2
- 主要终点
- Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years
研究概览
简要总结
The aim of this study is to test the impact of the managed ventricular pacing (MVP) mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed of any death, permanent atrial fibrillation, and cardiovascular hospitalizations.
详细描述
Kristensen et al. reported that AAIR pacing reduces atrial fibrillation (AF) development compared to DDDR pacing in sinus node disfunction patients.
Several authors have shown that, in patients with intact AV conduction, unnecessary chronic RV pacing can cause detrimental effects such as AF, left ventricular (LV) dysfunction and congestive heart failure. These findings arose the hypothesis that the non-physiologic nature of ventricular pacing may result in electrophysiological and LV remodeling changes that have potentially deleterious long-term effects.
The MVP mode, present in the Medtronic pacemaker EnRhythm, provides atrial based pacing with ventricular backup. It operates in true AAI(R) mode, it provides ventricular backup in case of a single conduction loss and converts to DDD(R) mode in case of persistent loss of AV conduction.
Aim of this study is to test the impact of the MVP pacing mode and atrial preventive and antitachycardia pacing therapies on the reduction of a composite clinical outcome composed by any death, permanent AF, cardiovascular hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I/Class II indications for dual chamber pacing
- •Previous implant of an EnRhythm dual chamber implantable pulse generator (IPG) since maximum 2 weeks
- •History of atrial arrhythmias (at least one electrocardiogram [ECG] or Holter documented episodes in the last 12 months)
排除标准
- •Less than 18 years of age
- •Pregnancy
- •Unwilling or unable to give informed consent or to commit to follow-up schedule
- •Medical conditions that preclude protocol required testing or limit study participation
- •Enrolled or intend to participate in another clinical trial during the course of this study
- •A life expectancy of less than 2 years
- •Patient is a candidate for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device implant
- •Anticipated major cardiac surgery within the course of this study
- •Permanent III degree AV-block or history of AV node ablation
- •History of permanent AF (as defined below)
- •AF ablation (left pulmonary veins) or other cardiac surgery < 3 months
- •Prior implant of defibrillator device or pacemaker (apart from EnRhythm IPG implanted within two weeks)
- •Uncontrolled hyperthyroidism
结局指标
主要结局
Composite Endpoint Composed by Death for Any Cause, Cardiovascular Hospitalization or Permanent AF at 2 Years
时间窗: 2 years
The outcome measurement is the 2 years incidence, calculated by Kaplan Meier survival analysis, of the composite endpoint composed by death for any cause, cardiovascular hospitalization or permanent AF.
次要结局
- Incidence of Permanent Atrial Fibrillation at 2 Years(2 years)
- Burden of Composite Clinical Endpoint(2 years)
- Cardiovascular Death(2 years)
- Clinical Outcome in All the Patients With MVP ON Between Patients With Optimized AV-delay and Patients Without Optimized AV-delay(2 years)
- Subjects' Symptoms(2 years)
- Heart Failure Medications(2 years)
- Any Hospitalization(2 years)
- Adverse Events(2 years)
- Development of Atrioventricular (AV) Block and Pacemaker Dependency(2 years)
- Predictors of Stroke, Transient Ischemic Attack (TIA) and Arterial Embolism(2 years)
- Incidence of Cardiovascular Hospitalizations at 2 Years(2 years)
- Persistent Atrial Fibrillation (AF)(2 years)
- Echocardiogram Data About Left Ventricular Fractional Shortening and Ejection Fraction and Left Atrium Dilatation(2 years)
- Death for All Causes at 2 Years(2 years)
- Cumulative Percentage of Ventricular Pacing(2 years)
- Atrial Fibrillation Burden(2 years)
- Time to Development of the Composite Endpoint Between All Randomized Subjects in the Three Arms in Subgroups of Patients(2 years)
- Frequency, Type, and Associated Cost of Health Care Utilization and Utility(2 years)