NL-OMON56818尚未招募不适用
CRT-DRIVE: Cardiac Resynchronization Therapy DeliveRy guided by non-Invasive electrical and VEnous anatomy assessment - CRT-DRIVE
XSpline S.p.A.0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Informed Consent signed by the subject
- •Age >=18 years at time of consent.
- •CRT indication according to the 2021 ESC guidelines on cardiac pacing and CRT
- •(class I and
- •IIA indication in patients with LBBB QRS morphology) or to 2017 AHA/ACC/HFSA
- •Patients in Sinus Rhythm, who are scheduled for CRT device implantation in
- •less than 3
- •QRS duration >=130 ms
- •Left bundle branch block
- •Left ventricular ejection fraction <=35%
- •Symptomatic heart failure NYHA class >= II
- •Documented stable medical treatment for at least 6 months
- •No cardiovascular intervention during the last 6 months
排除标准
- •History of persistent or permanent atrial fibrillation • Previous pacemaker
- •or ICD implantation • Indication to pacing due to bradycardia • Patients
- •considered for His bundle pacing or cardiac conduction pacing • Patients with
- •unstable angina • Subject experienced a recent myocardial infarction, within 40
- •days prior to enrollment • Subject underwent coronary artery bypass graft or
- •valve surgery, within 90 days prior to enrollment • Subject is post heart
- •transplantation, or is actively listed on the transplantation list, or has
- •reasonable probability (per investigator*s discretion) of undergoing
- •transplantation in the next year • Subject is implanted with a left ventricular
- •assist device • Subject is on continuous or uninterrupted infusion (inotropic)
- •therapy for heart failure • Subject has severe aortic stenosis (with a valve
- •area of <1.0 cm2 or significant valve disease expected to be operated within
- •study period) • Subject has congenital heart disease • Subject has a mechanical
- •right-sided heart valve • Subject has a life expectancy of less than one year
- •in the opinion of the investigator • Pregnant or breastfeeding women, or women
- •of child bearing potential and who are not on a reliable form of birth control
- •Subject is enrolled in one or more concurrent studies that would confound the
- •results of this study • Patients who have contraindications to CT scanning. •
- •Patients with chronic kidney diseases and estimated glomerular filtration rate
- •(eGMR) calculated based on CKD-EPI 2009 < 40 ml/min/1.73m2 • Patients with
- •diseases of the thyroid gland with impaired T3 and T4 levels
研究者
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