Trajectory Changes of Coronary Sinus Lead Tip and Cardiac Resynchronization Therapy Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 7
- 主要终点
- the two-dimensional echocardiographic volumetric response to cardiac resynchronization therapy
研究概览
简要总结
In chronic systolic heart failure patients submitted to cardiac resynchronization therapy, the study aims at assessing whether geometric variations in coronary sinus lead tip trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are predictive of the volumetric and clinical response to the treatment at six-month follow-up.
详细描述
Cardiac resynchronization therapy (CRT) has become a standard treatment in patients with symptomatic chronic systolic heart failure, reduced left ventricular (LV) function and wide electrocardiographic ventricular (QRS) complex, but approximately one third of patients do not respond to the treatment. Current ability to predict long-term response to CRT at implant is slight. Investigations have focused mostly on early prediction of the reversal of LV remodeling by means of LV pacing, which is delivered more frequently as biventricular pacing, combined with conventional right ventricular (RV) pacing. LV dyssynchrony areas have been identified as suitable targets for pacing, but no methods still can evaluate real-time, intra-operative acute effects of pacing on LV mechanics. This issue has become even more evident in the subset of CS implants of quadripolar leads, which offer relevant advantages but highlight the lack of methods for selecting the pacing configuration among the safe and effective ones.
Since LV pacing is currently delivered on the epicardium by a lead inserted in coronary sinus (CS) branches, the interface between the point of pacing delivery on LV surface and the underlying LV wall, and overall lead movements inside coronary sinus might describe some underlying myocardial mechanics. By means of a recently published fluoroscopy-based method, the trajectory of the electrode tip inserted in CS branches can be reconstructed in three-dimensions (3D) throughout the cardiac cycle. A preliminary clinical pilot study (Heart Rhythm 2013;10:1360) demonstrated that biventricular pacing acutely induced changes in trajectory geometry, which were correlated to the echocardiographic volumetric response to CRT at six-month post-implant follow-up. In responders only, biventricular pace abruptly determined a more circular shape. Such results were "hypothesis-generating" and are to be yet tested on a larger scale.
The study analyzes the predictive power of the changes in pacing cathode trajectory metrics occurring at the start of biventricular pacing with respect to both:
- the volumetric response to CRT, measured at six-month follow-up by a unique criterion;
- the clinical response to CRT, described at six-month follow-up by three clinical indices.
Secondarily, this study evaluates whether trajectory variations would be able to acutely guide the selection of the definitive LV pacing configuration in the subset of implants of a CS quadripolar lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Informed consent;
- •chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction ≤ 35%) and NYHA II-III or ambulatory IV class symptoms despite optimal medical treatment;
- •QRS complex on the surface electrocardiogram with left bundle branch block morphology and duration ≥ 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; QRS with with non-specific intraventricular delay lasting ≥ 150 ms;
- •a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly ≤ 45 beats per minute;
- •no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously;
- •a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate ≤ 25 breaths per minute;
排除标准
- •inability to give informed consent;
- •occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months;
- •any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats;
- •participation in any other competing clinical study, with the exception of registries ruled by National Health Service Authorities or Agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects:
- •the program of procedures/assessments requested by the present study;
- •the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients.
结局指标
主要结局
the two-dimensional echocardiographic volumetric response to cardiac resynchronization therapy
时间窗: six months
the volumetric response to cardiac resynchronization therapy defined by a reduction equal or greater than 15% in two-dimensional echocardiographic end-systolic volume (ml) at six-month in comparison with pre-implant assessment;
次要结局
- the clinical response to cardiac resynchronization therapy depicted by three metrics(six months)
研究者
Corrado Tomasi
Cardiologist, Chief Electrophisiologist of the Cardiovascular Department
Ospedale Santa Maria delle Croci