Assessing the Right Heart Remodeling After Transcatheter Tricuspid Edge-to-edge Repair

Launched by ISTITUTO AUXOLOGICO ITALIANO · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) to treat a heart condition known as secondary tricuspid regurgitation (STR), where the tricuspid valve doesn't close properly, leading to heart problems. The goal of the study is to see how this procedure affects the right side of the heart and to understand what factors might influence its success. Researchers will use advanced imaging techniques to look at the heart's shape and function before and after the treatment.

To participate in this trial, individuals must be over 18 years old and have severe STR that can be treated with T-TEER. They also need to be able to cooperate with the study requirements, including follow-up visits and imaging tests. Participants can expect to receive a less invasive treatment option, along with close monitoring of their heart health during the study. It’s important to note that certain conditions, such as severe kidney disease or pregnancy, may exclude someone from participating to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age\> 18 years
• • Severe STR, amenable to percutaneous treatment with T-TEER
• • Acceptance to be part of this study by signing the informed consent
• • Good enough acoustic window and ability to cooperate in order to obtain 3D echo data sets of cardiac structures with a minimum temporal resolution of 20 fps
• • Availability for clinical, CCT and, echocardiography follow-up visits
• Exclusion Criteria:
• • Pregnancy
• • Severe chronic kidney disease (GFR \<30 mL/min)
• • Hypersensitivity reactions to contrast media
• • Cardiovascular implantable electronic device-related (CIED) tricuspid regurgitation.
• • Bad acoustic window with inadequate echocardiographic images.