TriClip CED RWE Study

Launched by ABBOTT MEDICAL DEVICES · Apr 3, 2025

Keywords

ClinConnect Summary

The TriClip CED RWE Study is a clinical trial designed to learn more about the long-term health of patients who experience a condition called Tricuspid Regurgitation, which is when the heart's tricuspid valve doesn't close properly, leading to symptoms like fatigue or swelling. This study specifically looks at patients who have received a special heart procedure called the Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) using the TriClip system. It will also include a control group of patients who have not had this procedure, allowing researchers to compare outcomes and understand the benefits of the TriClip treatment.

To participate in this study, individuals must be at least 18 years old and have severe or greater Tricuspid Regurgitation symptoms. However, those with less severe cases or previous heart valve surgeries are not eligible. While the study is not yet recruiting participants, those who join will help researchers gather important information about the effectiveness of the TriClip procedure over time, which could lead to better treatment options for people with this condition in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 18 years of age at time of implant
• • Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
• Exclusion Criteria:
• • Patients with less than severe Tricuspid Regurgitation
• • Patients with a prior history of surgical or transcatheter tricuspid valve replacement
• • Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index