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Observational Study
. 2025 Aug 4;21(15):e869-e878.
doi: 10.4244/EIJ-D-24-01174.

Transcatheter valve repair of tricuspid regurgitation: 1-year outcomes from the TriCLASP study

Stephan Baldus  1 , Harald Lapp  2 , Niklas Schofer  3 , Tobias Geisler  4 , Tobias Kister  5 , Peter Lüdike  6   7 , Tienush Rassaf  6 , Jörg Hausleiter  8 , Kai Friedrichs  9 , Christian Frerker  10 , Edith Lubos  11 , Mirjam Kessler  12 , Konstantinos Spargias  13 , Thomas Schmitz  14 , Georg Nickenig  15 , Fabien Praz  16 , Sergio Berti  17 , Claudia Walther  18 , Dennis Mehrkens  1 , Bjorn Goebel  2 , Daniel Kalbacher  3 , Monika Zdanyte  4 , Maximilian von Roeder  5 , Amir Mahabadi  6 , Ludwig Weckbach  8 , Maria Ivannikova  9 , Christoph Marquetand  10 , Inge Dotz  11 , Matthias Gröger  12 , Michael Chrissoheris  13 , Mareike Eißmann  14 , Johanna Vogelhuber  15 , Nicolas Brugger  16 , Andreina D'Agostino  17 , Manuela Kroll  18 , Claire B Ren  19 , Philipp Lurz  5   20 , On Behalf Of The TriCLASP Study Investigators
Affiliations
Observational Study

Transcatheter valve repair of tricuspid regurgitation: 1-year outcomes from the TriCLASP study

Stephan Baldus et al. EuroIntervention. .

Abstract

Background: Patients with tricuspid regurgitation (TR) are at high risk for morbidity and mortality, with poorer outcomes associated with increasing TR severity. Tricuspid transcatheter edge-to-edge repair (T-TEER) has emerged as a promising treatment option.

Aims: TriCLASP is a prospective, single-arm, European post-market study evaluating the safety and effectiveness of T-TEER with the PASCAL system to treat patients with ≥severe TR.

Methods: The TriCLASP study enrolled 300 patients to evaluate the safety and performance of T-TEER. Major adverse events (MAE), reduction in TR grade, and clinical, functional, and quality-of-life outcomes were assessed at 1 year.

Results: Enrolled patients had a mean age of 80.1 years, 52.0% were female, and 75.8% had ≥severe TR. Tricuspid regurgitation was reduced to ≤moderate in 87.7% of patients (p<0.001). The composite MAE rate was 1.7% at 30 days and 12.7% at 1 year. Kaplan-Meier estimates for survival and freedom from heart failure hospitalisation (HFH) were 88.3±1.9% and 83.2±2.3%, respectively. Annualised HFH rates decreased by 72.2% in the 12 months pre- versus post-procedure (p<0.001). Significant functional and quality-of-life improvements were observed from baseline to 1 year, including 74.5% of patients in New York Heart Association Class I/II, a 29.4-metre increase in the 6-minute walk distance, and an 8.3-point increase in the Kansas City Cardiomyopathy Questionnaire score (p<0.001).

Conclusions: The 1-year results of the TriCLASP study confirm the safety and effectiveness of T-TEER with the PASCAL system in patients with ≥severe TR. Patients experienced significant TR reduction, low mortality, high freedom from HFH, and significant improvements in symptoms, functional capacity, and quality of life.

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Conflict of interest statement

S. Baldus has received a research grant from Abbott; and lecture fees from Abbott and Edwards Lifesciences. N. Schofer is a consultant for Edwards Lifesciences; and has received travel support from Abbott. T. Geisler has received personal fees (lecture honoraria) and institutional research grants from Edwards Lifesciences. P. Lurz has been a consultant to Abbott, Edwards Lifesciences, and Recor Medical. P. Lüdike has received research grants and honoraria for consulting and lectures from Edwards Lifesciences. T. Rassaf receives research funding from the Deutsche Forschungsgemeinschaft and Abbott; and receives honoraria for lectures or advisory boards from AstraZeneca, Bayer, Berlin Chemie, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, Novartis, and Pfizer. J. Hausleiter received personal fees and institutional grant support from Edwards Lifesciences. K. Friedrichs is a consultant for Edwards Lifesciences; and has received honoraria from Abbott. C. Frerker has received honoraria and travel support from Edwards Lifesciences and Abbott. E. Lubos has received lecture fees and research grants from Abbott and Edwards Lifesciences; honoraria for advisory board activities from New Valve Technology and Cardiovalve; and travel expenses from Cardiovalve, Abbott, and Edwards Lifesciences. K. Spargias has received honoraria or consultation fees from Edwards Lifesciences. T. Schmitz receives speaker and proctor honoraria from Edwards Lifesciences and Abbott. G. Nickenig has received honoraria for lectures or advisory boards from Abbott, Boston Scientific, Cardiovalve, Edwards Lifesciences, and Medtronic. F. Praz received consulting fees from Edwards Lifesciences during the conduct of the study. S. Berti receives honoraria and is a consultant for Procter & Gamble, Abbott, and Boston Scientific. M. Chrissoheris has received honoraria, lecture fees, and grant support from Edwards Lifesciences and Abbott. M. Eißmann receives honoraria or consultation fees from Edwards Lifesciences and Abbott. C.B. Ren reports institutional contracts for echocardiography core laboratory analyses with Boston Scientific, Edwards Lifesciences, NVT GmbH/Biosensors, and Shenqi Medical, for which she has received no personal compensation; and she has received honoraria from Abbott. The other authors have no conflicts of interest in relation to the contents of this paper to declare. H. Lapp, T. Kister, N. Schofer, T. Geisler, P. Lüdike, T. Rassaf, J. Hausleiter, M. Kessler, P. Lurz, and F. Praz report some overlap with PASTE registry enrolment.

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