Percutaneous interventions for Tricuspid Regurgitation: A systematic review of early clinical trials

Background Tricuspid Regurgitation is a prevalent and often undertreated valvular condition associated with poor prognosis when severe. Surgical intervention carries a high operative risk, especially in older patients or those with right ventricular dysfunction. In recent years, multiple percutaneous or transcatheter tricuspid valve interventions have emerged as alternatives, especially for patients who are considered unsuitable for surgery or at high surgical risk. Method This systemic review was conducted in accordance with PRISMA guidelines. A comprehensive search of PubMed, Cochrane Library, and ClinicalTrial.gov identified 74 articles, of which 9 early clinical trials were included. Data extraction and pooling was done, and analysis was performed based on functional outcomes like NYHA class, 6-minute walk distance along with quality of life, adverse events, and all-cause mortality. Results The procedural success rates across these early phase trials were consistently high (85% to 100%). Improvements in NYHA class were observed in 62% to 92% of patients, alongside meaningful gains in functional capacity and quality of life. Edge-to-edge repair devices demonstrated the most consistent functional benefit (91% NYHA improvement, mean + 85.5 m in 6MWA, + 17 KCCQ points), whereas valve replacement systems achieved reliable anatomical reduction with modest functional gains, and Mistral device showed marked improvements in a small feasibility cohort. The mortality rates were low but varied across the studies. Conclusion Early phase clinical trials demonstrated high procedural success rate, considerable improvement in functional status and quality of life. Larger randomized trials with extended follow-up are needed to confirm device durability and long-term clinical benefits.