Evaluating tricuspid valve changes after heart device implantation
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
This study is trying to see how getting a heart device affects the tricuspid valve in patients and if it leads to problems like tricuspid regurgitation over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT06914570 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who are undergoing new implantation of cardiac implantable electronic devices (CIEDs). It aims to assess the prevalence and mechanisms of tricuspid regurgitation (TR) that may develop post-implantation through advanced echocardiographic imaging techniques. The study will track morphological and functional changes in the tricuspid valve and right heart chambers over a period of up to five years, with follow-up assessments at discharge, three months, one year, and annually thereafter. Additionally, it seeks to identify risk factors associated with new or worsening TR following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing new CIED implantation and can provide informed consent.
Not a fit: Patients with a life expectancy of less than 12 months due to non-cardiac conditions or those with existing severe tricuspid valve issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of tricuspid regurgitation in patients with cardiac devices.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown the importance of monitoring tricuspid regurgitation in patients with cardiac devices.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan, MI
- San Luca Hospital — Milan, Mi, Italy (Recruiting)
Study contacts
- Principal investigator: Luigi Badano, MD, Ph.D. — Istituto Auxologico Italiano, IRCCS
- Study coordinator: Luigi P Badano, MD, Ph.D.
- Email: l.badano@auxologico.it
- Phone: +3902619112319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.