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临床试验/CTRI/2022/10/046216
CTRI/2022/10/046216尚未招募4 期

"CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES AFTER CONDUCTION SYSTEM PACING: A MULTI-CENTRIC OBSERVATIONAL STUDY"

Medtronic Inc1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年12月10日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
Medtronic Inc
入组人数
200
试验地点
1
主要终点
the

研究概览

简要总结

This is a prospective, Multi-centre, observational study of consecutive adult patients who require permanent pacemaker implantation for AV block/Bundle branch block and are taken up for conduction system pacing techniques ( His bundle pacing/Left bundle branch pacing)as per their clinical considerations to determine the pacing characteristics, clinical and echocardiographic outcomes during short term follow up.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Adult patients aged > 18 years who were subjected to either,
  • permanent left bundle branch area pacing for the atrioventricular block or bundle branch block, irrespective of the left ventricular ejection fraction (This subgroup essentially represents the CRT-P and Brady populations.), or
  • Those who had left bundle -optimized CRT.

排除标准

  • Patients not giving consent
  • Planned for conventional pacing or any form of physiological pacing other than LBB pacing 3.

结局指标

主要结局

the

时间窗: Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment

pacing characteristics, clinical and echocardiographic outcomes of adult patients who require permanent

时间窗: Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment

pacemaker implantation for AV block/Bundle branch block and are taken up for conduction system pacing

时间窗: Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment

techniques(His bundle pacing/Left bundle branch pacing) as per their clinical considerations

时间窗: Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment

次要结局

  • the composite endpoint among patients with a prespecified burden of ventricular pacing and individual outcomes.(Clinical Outcome will be accessed after 36 months(Review in every 6 months) of enrollment)

研究者

发起方
Medtronic Inc
申办方类型
Other [Medical Device company]

研究点 (1)

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