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Clinical Trials in Italy / NCT06914570
Recruiting Observational

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

NCT06914570 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Auxologico Italiano
Phase
Observational
Started
2024-05-01
Last updated
2025-04-06

Condition(s) studied

Cardiac Pacing, ArtificialTricuspid Valve Regurgitation, Non-rheumatic

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years * Patient able and willing to give informed consent in written form before the index procedure * Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up * Patients undergoing any new CIED implantation with or without transvalvular lead * Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers Exclusion Criteria: * Previous or present CIED * Life expectancy \< 12 months due to non-cardiac condition * Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months * Previous tricuspid valve intervention (transcatheter, surgical) * Participation in another study, which would lead to deviations from this trial protocol

Primary outcome measure(s)

  • Change in TR at least one grade after new CIED implantation — 5 years
    TR severity grade assessed using echocardiographic multi-parametric approach, including 3D echocardiography if possible.

Trial sites (1)

FacilityCityRegionStatus
San Luca Hospital Milan MI Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06914570 on ClinicalTrials.gov ↗ ← All trials in Italy