Study on New or Worsening Tricuspid Valve Leakage After First-Time Pacemaker or Defibrillator Lead Insertion Tracking Changes in Heart Valve Function and Related Health Outcomes for One Year

What this Trial Is About

Researchers are studying the occurrence of new or worsening tricuspid valve regurgitation TR in patients receiving a pacemaker or defibrillator with a transvenous lead. This observational study aims to prospectively assess patients undergoing cardiac electronic device implantation to document the frequency and predictive factors of TR development or progression, which has previously been reported mainly in retrospective analyses. The study monitors patients with three types of device leads standard pacemaker leads, implantable cardioverter defibrillator ICD leads, and left bundle branch area pacing LBBaP leads. Transthoracic echocardiograms TTE including 3D imaging of the tricuspid valve will be performed before and after implantation. Follow-up visits at 6 and 12 months will include TTE, ECG, NT-proBNP blood tests, and device checks to assess heart function and valve condition. Participants will be evaluated through imaging and heart function tests before and after device implantation, with scheduled follow-ups up to one year. The main outcome measured is worsening of TR by at least one grade. Secondary outcomes include TR severity, changes in NT-proBNP levels, and hospitalizations for heart failure. This comprehensive monitoring aims to improve understanding of TR related to device leads and support better patient care.

Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion