Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers (NCT06914570) | Clinical Trial Compass
RecruitingNot Applicable
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Italy350 participantsStarted 2024-05-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in TR at least one grade after new CIED implantation