临床试验/NCT06031519

NCT06031519进行中（未招募）不适用

Impact of Percutaneous Intramyocardial Septal Radiofrequency Ablation in Obstructive Hypertrophic Cardiomyopathy on Arrhythmias

Xijing Hospital1 个研究点分布在 1 个国家目标入组 350 人开始时间: 2023年8月22日最近更新: 2023年9月11日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 350
试验地点: 1
主要终点: All-cause and cardiovascular mortality

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after Percutaneous Intramyocardial Septal Radiofrequency Ablation. The main questions it aims to answer are:

To investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters
To analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after Percutaneous Intramyocardial Septal Radiofrequency Ablation and their relationships with clinical characteristics and procedural parameters

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Retrospective

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Subject with symptoms that limit daily activities (New York Heart Association functional class >II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
•Subject with a peak LVOT gradient≥50 mm Hg
•Subject volunteers for the Liwen procedure and received the procedure at the Hypertrophic Cardiomyopathy Center of Xijing Hospital.

排除标准

•Subject with a peak instantaneous Doppler LVOT gradient of <50 mm Hg
•Subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
•Subject has end-stage heart failure

结局指标

主要结局

All-cause and cardiovascular mortality

时间窗: From date of procedure until the date of first occurrence of outcome, assessed up to 1 years

All-cause and cardiovascular mortality (defined as sudden cardiac death, Heart Failure-related death, and heart transplant) were the primary outcomes.

次要结局

Arrhythmia(From date of procedure until the date of first occurrence of outcome, assessed up to 1 years)
Ventricular tacharrhythmia composite outcome(From date of procedure until the date of first occurrence of outcome, assessed up to 1 years)

研究者

发起方

Xijing Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Liu Liwen

Director

Xijing Hospital

研究点 (1)

Loading locations...

相似试验

已完成

不适用

Percutaneous Intramyocardial Septal Radiofrequency Ablation for Obstructive Hypertrophic Cardiomyopathy in ChildrenHypertrophic Cardiomyopathy, Obstructive

NCT06540183Xijing Hospital23

进行中（未招募）

不适用

A Prospective Incident Study of Arrhythmias in Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy

NCT04112290Mayo Clinic260

终止

不适用

Impact of Septal Vs Apical Pacing on Right and Left Ventricular PerformanceHeart BlockVentricular DysfunctionAtrioventricular BlockSick Sinus Syndrome

NCT01798043Abbott Medical Devices29

招募中

不适用

Transapical Beating-Heart Septal Myectomy in Patients With Symptomatic Nonobstructive Hypertrophic CardiomyopathyNonobstructive Hypertrophic Cardiomyopathy

NCT05952154Xiang Wei100

已完成

不适用

FIH Study With CBSOAtrial Septal Defect (ASD)Patent Foramen Ovale (PFO)

NCT01960491Carag AG15