跳至主要内容
临床试验/CTRI/2024/05/067950
CTRI/2024/05/067950尚未招募不适用

Study of impact of dual chamber pacing on right atrial function.

Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
The changes in the right atrial morphometric and functional parameters after dual chamber pacemaker implantation.

研究概览

简要总结

At the outset, we will obtain necessary approvals, including IRC (Institutional Review Committee), IEC (Institutional Ethics Committee) approval, and registration with CTRI (Clinical Trials Registry - India). Our study will focus on patients aged 18 years and above, who undergo dual chamber pacemaker implantation. Before the study, we will approach these patients and provide a detailed explanation of the research. Upon their understanding and agreement, informed consent will be obtained. Demographic details and clinical data and treatment receiving will be collected using proforma. Echocardiography will be done as a standard care in which RA size, RA area, RV wall thickness, RVOT diameter, TAPSE, IVC diameter and E/A ratio will be measured. Speckle-tracking echo will be done to measure RA strain, Strain rate and RV strain. Echocardiography will be done at 3 different dates. First echo will be done 1-2 days prior to pacemaker implantation. Second echo will be done 1-2 days after the pacemaker implantation and the third echo will be done after 1 month of procedure during follow-up. Patients with RV pacing of more than 40% will be included in this study. There will be no need for additional visits or follow-up in this study.

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

  • Individuals with dual chamber pacemaker Patient with RV pacing more than 40%.

排除标准

  • Structural heart disease Previous DDDR Previous cardiac surgerires or interventions Dysfunctional pacemakers Presence of documented cardiac arrhythmias Known RV dysfunction.

结局指标

主要结局

The changes in the right atrial morphometric and functional parameters after dual chamber pacemaker implantation.

时间窗: RA structure and function will be assessed through echo on 1-2 days before , 1-2 days after and 1 month post pacemaker implantation.

次要结局

  • Right Ventriuclar dysfunction & its co relation with right atrial functional & morphometric parameters.(RV function will be assessed through echo on 1-2 days before, 1-2 days after & 1 month post pacemaker implantation.)

研究者

发起方
Kasturba Medical College, Manipal, 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

DR Harshvardhan N M

MANIPAL ACADEMY OF HIGHER EDUCATION

研究点 (1)

Loading locations...

相似试验