Actively Recruiting
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Led by Istituto Auxologico Italiano · Updated on 2025-04-06
350
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 18 years
- Able and willing to give written informed consent before the procedure
- Understands the study purpose, risks, and benefits and agrees to participate in all follow-ups
- Undergoing any new CIED implantation with or without transvalvular lead
- Sufficient imaging quality on transthoracic echocardiography to assess tricuspid regurgitation severity and right heart chamber morphology
You will not qualify if you...
- Previous or present cardiac implantable electronic device (CIED)
- Life expectancy less than 12 months due to non-cardiac conditions
- Tricuspid valve stenosis of any severity or severe tricuspid regurgitation planned for intervention within 12 months
- Previous tricuspid valve intervention (transcatheter or surgical)
- Participation in another study that conflicts with this trial protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
San Luca Hospital
Milan, MI, Italy, 20149
Actively Recruiting
Research Team
L
Luigi P Badano, MD, Ph.D.
CONTACT
M
Michele Tomaselli, MD, Ph.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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