PROTECT-PACE STUDY - The Protection of Left Ventricular Function During Right Ventricular Pacing. Does Right Ventricular High-septal Pacing Improve Outcome Compared With Right Ventricular Apical Pacing?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 18
- 主要终点
- Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
研究概览
简要总结
This study will be done in patients who require the implantation of a cardiac pacemaker (an electronic device that controls the heartbeat) for complete heart block (a heart rhythm abnormality resulting in a slow heart beat). Pacemakers regulate the heart beat by delivering pulses of electricity through special wires (pacing leads) which are placed inside the heart.
This study will compare two groups of pacemaker patients. Each group will have their pacing leads placed in a particular location in the heart. The purpose of the study is to show whether the position used in one group is better for maintaining effective heart function compared to the position used in the other group.
The leads in one group will be placed in a position called the Right Ventricular Apex. This is the traditional and most frequently used position for pacemaker leads.
The leads in the other group will be placed in a position called the Right Ventricular High Septum. This is a less commonly used position, but may result in health benefits for the patients compared with the Right Ventricular Apex.
详细描述
There is an increasing amount of evidence to suggest that other positions in the heart may be more effective than the conventional Right Ventricular Apex (RVA) position for restoring good heart function. The best site to place a lead has not yet been proven.
This is a study comparing the long term clinical effects of two different lead positions. The measurements taken to assess the clinical effects include:
- the effectiveness of the heart's pumping action (as measured by ultrasound scans)
- measurements of how far patients can walk in 6 minutes
- analysis of blood samples
- collection of information from the pacemaker about heart rhythm problems
Half of the patients in the study will receive conventional leads placed in the more common RVA position in the heart. The other half will receive a relatively new type of lead placed in what is called the Right Ventricular High Septal (RVHS) position.
In order to fairly compare the outcomes of these two different lead positions this study has been designed as a 'randomized', 'blind' trial. This means that the group which patients will be entered into will be chosen at random and patients will not be told which group they are in.
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 with high grade AV block and sinus rhythm, scheduled to undergo dual chamber pacemaker implantation OR patients with high grade AV block and permanent atrial fibrillation, scheduled to undergo single chamber ventricular pacemaker implantation.
- •Patients aged 18 years or older.
排除标准
- •Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
- •Patients following junctional ablation.
- •Patients with a Myocardial Infarction within three months prior to enrollment.
- •Patients that received bypass surgery within three months prior to enrollment.
- •Patients that had a valve replacement within three months prior to enrollment or patients with a mechanical right heart valve.
- •Patients where a right ventricular lead cannot be placed i.e. complex congenital heart disease.
- •Patients with hypertrophic obstructive cardiomyopathy.
- •Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or hemodynamically significant aortic stenosis.
- •Previous implanted pacemaker or cardioverter defibrillator.
- •Known paroxysmal atrial fibrillation or a documented episode of atrial fibrillation prior to enrollment.
- •Patients on amiodarone therapy within the last six months prior to enrollment.
- •Terminal conditions with a life expectancy of less than two years.
- •Participation in any other study that would confound the results of this study.
- •Psychological or emotional problems that may interfere with the volunteer's ability to provide full consent or fully understand the purposes of the study.
- •Pregnant patients or patients who may become pregnant during the time-scale of the study.
研究组 & 干预措施
RV Apex
干预措施: RV lead placement site (Other)
RV High Septum
干预措施: RV lead placement site (Other)
结局指标
主要结局
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Per Protocol Cohort).
时间窗: At 2-year follow-up
Change in Left Ventricular Ejection Fraction From Baseline to 2 Years (Intent to Treat Cohort).
时间窗: At 2-year follow-up
次要结局
- All Cause Mortality(At 5-year follow-up (study extension))
- Brain Natriuretic Peptide Levels (Per Protocol Cohort)(At 2-year follow-up)
- 6 Minute Hall-Walk Distance (Per Protocol Cohort)(At 2-year follow-up)
- Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)(At 5-year follow-up (study extension))
- Incidence of Stroke(At 5-year follow-up (study extension))
- Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)(At 5-years follow-up (study extension))
- Worsening of Heart Failure(At 5-year follow-up (study extension))
- Echocardiographic Measures of Left Ventricular Dyssynchrony(At 2-year follow-up)
- 6 Minute Hall-Walk Distance (Intent to Treat Cohort)(At 2-year follow-up)
- Brain Natriuretic Peptide Levels (Intent to Treat Cohort)(At 2-year follow-up)
- Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Intent to Treat Cohort)(At 2-year follow-up)
- Incidence of Atrial Tachyarrhythmia Recorded by the Pacemakers (Per Protocol Cohort)(At 2-year follow-up)