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

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 31, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how the implantation of cardiac devices, which help manage heart rhythms, affects the tricuspid valve and the right side of the heart. Specifically, the study wants to see if new or worsening tricuspid regurgitation (TR)—a condition where the valve doesn't close properly, leading to blood leaking backward—occurs after these devices are placed. Researchers will use advanced imaging techniques to follow patients for up to five years, assessing not only how common this issue is but also what factors might contribute to it and how it impacts overall health.

To be eligible for the trial, participants must be at least 18 years old and agree to take part by providing written consent. They should be undergoing a new cardiac device implant, and their heart imaging must meet certain quality standards. However, people with certain heart conditions or those who have had similar procedures in the past are not eligible. Participants can expect regular check-ups and imaging assessments over several years to help researchers understand the effects of these devices on heart function.

Gender

ALL

Eligibility criteria

• 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