NCT06914570

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive echocardiographic assessment, including advanced three-dimensional (3D) transthoracic and transesophageal imaging. The primary objective of this study is to assess the prevalence and leading mechanism of new or worsening TR, defined as an increase of at least one grade on a five-grade scale, after new CIED implantation. Secondary objectives include clinical and echocardiographic endpoints at discharge, three months, one year, and annually for up to five years. They can be summarized as follows: 1. to evaluate morphological and functional changes (remodeling) of the tricuspid valve (TV) apparatus and right-sided heart chambers in patients undergoing new CIED implantation. 2. to identify risk factors for new or worsening TR after CIED implantation on an anatomical, procedural, and clinical level. 3. to determine the clinical impact of new or worsening TR after CIED implantation. 4. to explore the treatment strategies for lead-related TR (observational).

Conditions

• Cardiac Pacing, Artificial
• Tricuspid Valve Regurgitation, Non-rheumatic

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2029-02-24
• First posted: 2025-04-06
• Last updated: 2025-04-06

Locations

1 site across 1 country: Italy