Multiparametric CMR Assessment of Apical Versus Septal Pacing Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Ventricular Ejection fraction
研究概览
简要总结
Despite considerable effort the optimal site to place a pacemaker lead at the time of pacemaker implant remains unclear. Historically pacemaker leads have always been inserted at the bottom (apex) of the heart. It is suggested that a lead placed at the apex is associated with an increase in heart rhythm problems and also heart failure (impaired pumping function). The top of the ventricle (septum) has been investigated as an alternative site and is now routinely used by some centres. Previous estimation of the hearts pumping function (ejection fraction) has been limited to the use of echo (sound waves). Echo is not sensitive enough to detect small changes in the ejection fraction reliably (measure of pumping function of heart). The gold standard for measurement of ejection fraction is MRI (using magnets). Previous pacemakers have not been compatible with MRI scans. The latest generation of pacemakers are now able to be safely scanned within an MRI scanner. This allows a much more accurate estimation of the effects of a pacemaker on the ejection fraction which has not yet been studied.
The investigators plan to study those patients undergoing a pacemaker implant and ablation procedure as part of their standard care.
Individuals will have an exercise test, blood test used to measure biomarkers and fill in a symptom questionnaire.
Individuals will have a Cardiac MR compatible pacemaker fitted and 2 ventricular leads will be inserted, one apically and one septally. Only one lead will be used at any given time. Individuals will then undergo their planned AV node ablation.
Following this they will have a cardiac MR scan. Further MRI scans will be performed at 9 and 18 month intervals, as will symptom questionnaires, blood tests (BNP) to determine heart muscle strain, exercise testing and echocardiograms.
The hypothesis is that a lead placed on the septum will produce superior cardiac performance over the short and long term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients in permanent Atrial Fibrillation (AF)requiring a pacemaker on clinical grounds (tachycardia/bradycardia syndrome or requiring an AV node ablation)and AV node ablation or a pacemaker for rate control)
- •Patients aged 18 to 85 years old.
- •Able to consent for study.
排除标准
- •Patients with moderate to severe LV dysfunction (EF < 40%).
- •Any contraindication to an MRI scan.
- •Patients indicated for an Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.
- •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 e.g. complex congenital heart disease.
- •Patients with hypertrophic obstructive cardiomyopathy.
- •Patients with acute coronary syndrome, unstable angina, severe mitral regurgitation and/or haemodynamically significant aortic stenosis.
- •Previous implanted pacemaker or cardioverter defibrillator.
- •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
Apical Pacing
Pacemaker programmed to pacing the heart at apex for 9 months.
干预措施: Apical pacing (Procedure)
Apical Pacing
Pacemaker programmed to pacing the heart at apex for 9 months.
干预措施: Septal pacing (Procedure)
Apical Pacing
Pacemaker programmed to pacing the heart at apex for 9 months.
干预措施: Pacemaker (Device)
Septal Pacing
Pacemaker programmed to pacing the heart at the septum for 9 months.
干预措施: Apical pacing (Procedure)
Septal Pacing
Pacemaker programmed to pacing the heart at the septum for 9 months.
干预措施: Septal pacing (Procedure)
Septal Pacing
Pacemaker programmed to pacing the heart at the septum for 9 months.
干预措施: Pacemaker (Device)
结局指标
主要结局
Ventricular Ejection fraction
时间窗: 18 months
Comparison of % change in Left and Right Ventricular Ejection Fractions between apical and septal pacing groups as measured on MRI.
次要结局
- Level of MMP2(18 months)
- Levels of BNP(18 months)
- 6 minute walk tests(18 months)
- Level of Pro-BNP(18 months)
- Exercise Capacity as measured by CPEX(18 months)
- Level of MMP-1(18 months)
- Level of Troponin(18 months)
- Quality of life measures SF36(18 months)
- Level of ICTP(18 months)
- Level of MMP-9(18 months)
- MRI measures of Left and Right ventricular dyssynchrony(18 months)
- Level of GDF-15(18 months)