Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Recruiting now
Conditions studied: Cardiac Pacing, Artificial, Tricuspid Valve Regurgitation, Non-rheumatic
In brief
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).
Key facts
- Study ID
- NCT06914570
- Run by
- Istituto Auxologico Italiano
- People needed
- 350
- Starts
- 2024-05-01
- Expected to finish
- 2029-02-24
- Last updated by the study team
- 2025-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- San Luca Hospital — Milan, MI, Italy (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.