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临床试验/NCT05555992
NCT05555992Unknown不适用

Electrical Activation Mapping Guided Tailor Made Approach for Cardiac Resynchronization Therapy for Non-responder

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2020年1月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
18
试验地点
1
主要终点
Left Ventricle end systolic volume reduction

研究概览

简要总结

Background Cardiac Resynchronization Therapy (CRT) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. However, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving CRT. Conventionally the surgical approach of CRT is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. However, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to CRT. Purpose of the clinical investigation. The purpose of the Electrical Activation Guided CRT for Nonresponders Study is to study the effectiveness of an addition of Hisbundle pacing approach to CRT nonresponder by direct His-bundle pacing to improve the responder rate of nonresponder of conventional CRT and a tailored made approach to CRT procedure by using a noninvasive globally mapping system studying the electrical conduction under different approaches to delivery CRT. The pacing approach that optimally corrects conduction abnormality will be determined before the actual addition of new lead procedure.

Conduct of the Investigation This study will include 18 patients already implanted with device delivering conventional CRT that known to have no response to the conventional CRT after 6 months of the CRT therapy from Prince of Wales Hospital, Hong Kong. You will be followed in the device clinic as per usual care after your participation in the study is completed.

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

入选标准

  • Adult (aged 18 or above) of both sexes
  • Ischemic or non-ischemic cause of heart failure
  • QRS duration > 120 ms, non -LBBB type of conduction disturbance
  • NYHA class III or above
  • Informed consent by the patient
  • Already received stable dose of guideline directed medical therapy for at least 3 months

排除标准

  • LBBB patients
  • Pregnant women
  • Participation in another study
  • Patient with contraindication to left ventricle catheterization by a retrograde aortic approach

研究组 & 干预措施

Treatment

Experimental

干预措施: Electrical Activation Mapping Guided Cardiac resynchronization therapy (Device)

结局指标

主要结局

Left Ventricle end systolic volume reduction

时间窗: 6 months

The responder rate of greater than 10% of LV end systolic volume reduction measured by echocardiogram.

次要结局

  • Electrical desynchrony index(During procedure)
  • Hemodynamic response monitoring(During procedure)
  • Cine images and chest X ray(6 months)
  • Echocardiogram parameters: left ventricular systolic and diastolic volume(6 months)
  • Device set-up parameter: defibrillation threshold(6 months)
  • Change in quality of life(6 months)
  • Change in 6 minute hall walk test(6 months)
  • Device set-up parameter: lead impedance(6 months)
  • Procedure duration of different methods of CRT delivery(During procedure)
  • Implantation success rate of different methods of CRT delivery(During procedure)
  • Device set-up parameter: defibrillation sensitivity(6 months)
  • Echocardiogram parameters: degree of mitral regurgitation(6 months)
  • Post-operation Complication rate(6 months)
  • Echocardiogram parameters: left ventricular ejection fraction(6 months)
  • Echocardiogram parameters: strain imaging(6 months)
  • Change in New York Heart Association (NYHA) class(6 months)
  • Change in HF Patient Global Assessment Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Bryan Ping Yen YAN

Professor

Chinese University of Hong Kong

研究点 (1)

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