PreFER MVP for Elective Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant
研究概览
简要总结
The purpose of this study is to demonstrate the benefit of MVP in pacemaker and implantable cardioverter defibrillator (ICD) patients with a history of right ventricular pacing.
详细描述
A number of clinical studies (Danish I, Danish II, David, MOST) over the past few years have shown that, in patients with intact atrioventricular (AV) conduction, unnecessary chronic right ventricular (RV) pacing can cause a variety of detrimental effects, including atrial fibrillation (AF), left ventricular (LV) dysfunction, and congestive heart failure (CHF). These effects are believed to result from the mechanical dyssynchrony and ventricular chamber dysfunction that occurs with chronic, single-site, apical ventricular stimulation.
Therefore a new pacing modality, Managed Ventricular Pacing (MVP), was designed to give preference to natural heart activity by minimizing unnecessary right ventricular pacing. This is accomplished by automatically switching between single chamber atrial and dual-chamber pacing based on specific patient needs.
MVP is an atrial-based dual-chamber pacing mode that provides functional AAI/R pacing with ventricular monitoring and back-up DDD/R pacing only as needed during episodes of AV block.
The reversibility of the detrimental effects caused by ventricular pacing has been initially investigated in small patient populations with short pacing durations in AAI and needs further investigation.
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)
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
- •Patients implanted with a dual chamber device (including atrial synchronous ventricular inhibited [VDD]) for a minimum time duration of 2 years
- •Planned to be replaced or replaced with a device including the MVP feature
- •Have had more than 40% ventricular pacing documented with their old device over a period of at least 4 weeks before enrollment or device replacement.
- •Pacing should not be caused by a switch to the single chamber pacing (VVI) mode because of battery depletion
- •Have signed the informed consent
- •Have no need to change the pacing mode or the atrioventricular (AV) intervals.
排除标准
- •Patients with a cardiac resynchronization therapy (CRT) indication
- •Permanent AF
- •Permanent AV block
- •Inability to complete follow-up visits at a study center.
- •Unwillingness or inability to cooperate or give written informed consent, or the patient is a minor, and legal guardian refuses to give informed consent
- •Planned cardiovascular intervention
- •Inclusion in another clinical trial that will affect the objectives of this study
- •Neurocardiogenic syncope as primary implantable pulse generator (IPG) indication.
结局指标
主要结局
Time to Event Analysis: Number of Patients Who Experienced the First Cardiovascular Hospitalization Within 2 Years Post-implant
时间窗: Implant to 2 years post-implant
Time to first event of cardiovascular (CV) hospitalization from implant to 2 years post-implant. Hospitalization is defined as: * admission to hospital involving one overnight stay or * emergency room / office visits that result in cardioversions or acute treatment of worsened cardiac condition Cardiovascular is defined as new or worsening: * heart failure (HF), * angina, * myocardial infarction (MI), * any arrhythmia, * stroke, * transient ischemic attack (TIA), * acute peripheral vascular emergencies, * pulmonary embolism.
次要结局
- Time to Event Analysis: Number of Patients Who Experienced Death or First Cardiovascular (CV) Hospitalization Within 2 Years Post-implant.(Implant to 2 years post-implant)
- Time to Event Analysis: Number of Patients With Persistent AT/AF Within 2 Years Post-implant(Implant to 2 years post-implant)
- Time to Event Analysis: Number of Patients With Permanent AF Within 2 Years Post-implant(Implant to 2 years post-implant)
- Ventricular Pacing Percentage(Implant to 2 years post-implant)
- Incidence of High Voltage Therapies(Implant to 2 years post-implant)
- Patient Symptoms(Implant to 2 years post-implant)
- Health State(2 years post-implant)
- Change in New York Heart Association (NYHA) Functional Class(Baseline, one year and 2 year post-implant)
- Change in Left Ventricular Ejection Fraction (LVEF,%) Over 2 Years Time(Implant to 2 years post-implant)
- Change in Use of Anticoagulation(Implant to 2 years post-implant)
- Number of Cardiovascular Related Hospitalizations(Implant to 4 years post-implant)
- Change in the Use of Cardiovascular Medication Over Time(Implant to 2 years post-implant)
- Time to Event Analysis: Number of Patients Who Died Within 2 Years Post-implant(Implant to 2 years post-implant)
- Stroke(Implant to 2 years post-implant)
- Change in PR Interval, Change in QRS Duration and Change in P-wave Duration(Implant to 2 years post-implant)
- Duration of Cardiovascular Related Hospitalizations(Implant to 4 years post-implant)
- Incidence of Class I Pacemaker (Implantable Pulse Generator = IPG) Indication in Implantable Cardioverter Defibrillator (ICD) Patients(Implant to 2 years post-implant)
- Atrial Pacing Percentage(2 years post-implant)