Study of Changes in Tricuspid Valve and Right Heart Chambers After New Cardiac Implantable Electronic Device CIED Implantation Evaluation of Tricuspid Regurgitation and Heart Function Over Five Years

What this Trial Is About

Researchers are studying the occurrence and effects of tricuspid regurgitation TR after the implantation of cardiac electronic devices CIED using detailed echocardiographic imaging, including advanced 3D transthoracic and transesophageal techniques. This observational study aims to identify how often new or worsening TR occurs following CIED implantation, what causes it, and its clinical impact. The study also explores treatment approaches for lead-related TR and monitors patients over several years to understand heart changes after device implantation. Patients included in the study are those undergoing new CIED implantation with or without leads crossing the tricuspid valve. The study involves comprehensive echocardiographic assessments to evaluate the tricuspid valve and right heart chambers. Follow-up assessments are scheduled at discharge, three months, one year, and then annually up to five years. The study observes morphological and functional heart changes, identifies risk factors, and tracks clinical outcomes related to TR after device implantation. Participants will undergo regular echocardiographic imaging and clinical evaluations throughout the study period, including assessments of heart function and symptoms. Researchers will record outcomes such as changes in TR severity, mortality rates, heart failure hospitalizations, functional heart classification, and any interventions on the tricuspid valve. The study lasts up to five years, allowing detailed observation of the hearts response to CIED implantation over time, with continued monitoring of clinical and imaging findings.

Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers