SCar Location and Acute Haemodynamic Response to MultiPoint Pacing in Patients With Ischemic Cardiomyopathy (SCAR MPP Study)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium
研究概览
简要总结
Cardiac Resynchronization Therapy (CRT) is a proven treatment for heart failure.
CRT consists of a special pacemaker with two/three leads (insulated wires which take the electrical impulses from the device to the heart), one in the right ventricle, one in a vein on the outer surface of the left ventricle (in a vessel called coronary sinus or CS) and sometimes one in the right atrium (right top chamber of the heart). Tiny electrical impulses are simultaneously sent to the ventricles to make them beating together again in a more synchronised pattern. This leads to a coordinated, synchronous pumping action that, in most patients, translates into improved heart failure symptoms and improved quality and quantity of life, reducing the chance of being admitted to hospital with worsening heart failure. Unfortunately up to one third of the patients do not benefit from CRT therapy and to date there are no useful criteria to predict the response to CRT.
In an effort to improve the response rate to CRT, alternative methods have been developed. In particular, a new technology called MultiPoint Pacing (MPP) (St. Jude Medical, Sylmar, CA) has recently become available. It allows simultaneous stimulation of 2 different points in the left ventricle by using a single lead with four electrodes. This strategy should improve the pumping function of the heart by recruiting a larger mass of muscle. Although MPP is as safe and as effective as standard CRT pacing, the improvements to date in the heart pump function it gives over standard CRT pacing are variable and small.
Recent evidence suggests that MPP pacing could be particularly beneficial in some subgroups of patients, in particular patients with a previous history of heart attack resulting in scar formation in the left ventricle.
The investigators hypothesize that MPP works better when the lead is closer to the scar because this allows recruitment of areas with slow conduction, thus increasing synchronization further.
To this aim, they plan to compare, in each patient, the acute response produced by MPP on the cardiac function when the CS lead is placed close to myocardial scar and when it is placed far from scar respectively.
详细描述
A prospective single-centre pilot study will be conducted to investigate this topic. Fifteen patients, with a history of previous ST Elevation Myocardial Infarction (STEMI) resulting in myocardial scar and elected to CRT implant at the OUH, will be enrolled in this study.
Compared to standard practice, additional research investigations will be a baseline visit for eligibility assessment, informed consent and pre-CRT implant cardiac MRI, a three-dimensional electroanatomical map reconstruction of the CS venous system during the standard CRT implant and the evaluation of the acute haemodynamic response (AHR, percentage increase of LV-dP/dT max) of MPP over conventional single-site LV pacing during the CRT implant.
The cardiac Magnetic Resonance Imaging (MRI) will be performed in each patient 1-2 weeks before the CRT implant during the baseline visit. It will provide information regarding presence and location of myocardial scar and anatomy of the CS venous system.
A de-novo CRT implant will be performed under fluoroscopic guidance as per standard care. All subjects will be implanted with a regulatory approved St. Jude Medical CRT device compatible with MPP feature (models n° CD3271-40(Q), CD3371-40(Q), CD3371-40C(QC) or newer) and St. Jude Medical quadripolar left ventricular lead (Quartet 1458Q or newer). The choice of the right ventricular and right atrial leads will be left to the operator. After implant of the right ventricular and right atrial leads, a CS venogram will be then performed as per standard practice (see intervention section for more details).
A three-dimensional electroanatomical map of the CS venous system will be constructed with Precision mapping system and a Biotronik Vision wire (Biotronik Se & Co. KG, Berlin, Germany) by using the CS venogram as a guide. The map will be merged with the correspondent cardiac MRI images in order to locate the myocardial scar in respect to the CS branches. This will allow the identification of two target CS branches for the study measurements, one located in the peri-infarct region and one located in the remote myocardium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age of 18 years or over
- •Previous STEMI (> 3 months before enrolment) and consequent LV scar;
- •Standard indication to CRT-D (NYHA functional class III-IV despite optimal medical therapy, LV ejection fraction (LVEF) ≤35 %, QRS duration ≥120 msec, LBBB);
- •Sinus rhythm;
- •Will and ability to give informed consent for participation in the study.
排除标准
- •Pregnancy, trying for a baby or breast feeding;
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- •Inability to tolerate MRI scanning (e.g. claustrophobia, unable to lie flat)
- •Contraindications to MRI scanning (e.g. implantable devices, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium);
- •Significantly impaired renal function (eGFR < 30ml/min);
- •History of allergy to cardiac MRI contrast media;
- •Severe claustrophobia.
研究组 & 干预措施
Patients with myocardial scar
Patient with previous STEMI resulting in myocardial scar, elected to CRT implant
干预措施: Cardiac MRI with gadolinium contrast (Diagnostic Test)
Patients with myocardial scar
Patient with previous STEMI resulting in myocardial scar, elected to CRT implant
干预措施: 3D reconstruction and location of coronary sinus venous system relative to myocardial scar (Diagnostic Test)
Patients with myocardial scar
Patient with previous STEMI resulting in myocardial scar, elected to CRT implant
干预措施: Acute haemodynamic measurements during CRT implant (Diagnostic Test)
结局指标
主要结局
Comparison of Acute Haemodynamic Response Produced by MPP in Peri-infarct Region and in the Remote Myocardium
时间窗: Day 1
Comparison between 1. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the peri-infarct region and 2. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over spontaneous ventricular activation in the remote myocardium
Comparison Between MPP and Standard CRT Pacing in Terms of Acute Haemodynamic Response
时间窗: Day 1
Percentage change of LV dP/dT max produced by MPP over conventional single-site LV pacing in the peri-infarct region compared to the remote myocardium Comparison between 1. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT pacing in the peri-infarct region and 2. percentage change of maximal left ventricular pressure over time (LV-dP/dTmax) produced by multipoint pacing (MPP) over conventional CRT in the remote myocardium
次要结局
未报告次要终点
研究者
Tim Betts MD MBChB FRCP
Principle Investigator, Consultant Cardiologist
Oxford University Hospitals NHS Trust