跳至主要内容
临床试验/CTRI/2025/02/080262
CTRI/2025/02/080262已完成不适用

Assessing the influence of RV lead position on tricuspid regurgitation using 4 d echocardiography

Kasturba Medical College Manipal Academy of Higher Education Manipal1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
1
主要终点
Tricuspid regurgitation

研究概览

简要总结

This study will be conducted in the Department of Cardiology at Kasturba Hospital, Manipal, following IEC approval and CTRI registration. It aims to explore the effects of right ventricular (RV) lead positioning on tricuspid regurgitation (TR) and right atrial (RA) function using 4D echocardiography. The primary objective will be to determine how RV lead placement influences TR. Secondary objectives will include comparing the accuracy of 4D echocardiography and fluoroscopic landmarks in identifying the pacing site, as well as evaluating the acute and short-term effects of permanent pacemaker implantation (PPI) on RA and RV function. Participants will undergo echocardiographic assessments 1-2 days before the procedure, immediately after implantation, and at a three-month follow-up. Additionally, post-implantation, the study will document fluoroscopic lead placement and landmarks. This research will address the gap in understanding the impact of RV lead positioning on TR and RA changes, with the potential to reveal whether RA dysfunction precedes RV issues, thereby enhancing clinical management for symptomatic patients with no further visits or follow-ups required beyond these assessments.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients undergoing permanent pacemaker implantation(PPI).

排除标准

  • Structural heart disease Dysfunctional pacemakers Previous cardiac surgeries/interventions Poor echo window.

结局指标

主要结局

Tricuspid regurgitation

时间窗: At the recruitment | At three months

Lead position in fluoroscopy and 4D echocardiography

时间窗: At the recruitment | At three months

Lead traversing through tricuspid valve in 4D echocardiography

时间窗: At the recruitment | At three months

次要结局

  • RA And RV morphometric and functional parameters(At the recruitment)

研究者

发起方
Kasturba Medical College Manipal Academy of Higher Education Manipal
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ganesh G Kamath

Manipal college of health professions

研究点 (1)

Loading locations...

相似试验

Study on how pacemaker lead position will effect... | 临床试验