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临床试验/NCT07077928
NCT07077928已完成不适用

Effects of Upgrading From Right Ventricular Pacing to Cardiac Resynchronization Therapy and Comparison With Dual-Chamber Defibrillator

Bursa Postgraduate Hospital1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
307
试验地点
1
主要终点
All cause mortality and hospitalization for heart failure

研究概览

简要总结

Patients who consecutively underwent de novo CRT implantation, CRT upgrade, and DDDR ICD implantation at the Cardiology Clinic of Bursa Postgraduate Hospital between January 2019 and December 2023 according to the European Society of Cardiology (ESC) guideline criteria were included in the study.

详细描述

100 patients receiving de-novo CRT, 38 patients upgrading from RV pacing to CRT, and 169 patients receiving a DDDR-ICD implantation were included the study. Inclusion criteria were left ventricular ejection fraction lower than 35% and either QRS longer than 130ms for CRT groups or QRS≤120ms for the DDDR-ICD group. Primary endpoints were all-cause mortality and hospitalization for heart failure during a follow-up period extending up to 5 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • De novo CRT group:
  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • New York Heart Association (NYHA) class II-IV,
  • QRS >130 ms,
  • patients with atrial fibrillation (AF) who converted to sinus rhythm and who remained symptomatic despite 3-6 months of guideline-directed medical therapy.
  • CRT upgrade group:
  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • NYHA class II-IV,
  • QRS duration >130 ms with RV pacing,
  • > 20% RV pacing rate,
  • patients with AF who converted to sinus rhythm, at least 6 months since pacemaker implantation, and symptomatic despite 3-6 months of guideline directed medical therapy.
  • DDDR ICD group:
  • Sinus rhythm,
  • age higher than 18,
  • EF lower than 35%,
  • QRS ≤120 ms,
  • NYHA class II-IV,
  • patients with AF converted to sinus rhythm,
  • receiving guideline-directed medical therapy.

排除标准

  • patients with atrial fibrillation
  • LV EF higher than 50 %
  • NYHA Class 1
  • Patients with active infection or cancer

结局指标

主要结局

All cause mortality and hospitalization for heart failure

时间窗: 24 months

次要结局

未报告次要终点

研究者

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

Hasan ARI

Professor Doctor

Bursa Postgraduate Hospital

研究点 (1)

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