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

NCT06914570 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2025-04-06

No results posted yet for this study

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

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Luigi Badano, MD, Ph.D. · Istituto Auxologico Italiano, IRCCS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-01
Primary Completion
2026-05-01
Completion
2029-02-24

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06914570 on ClinicalTrials.gov