Transcatheter tricuspid valve repair using the PASCAL system, combined with optimal medical therapy, significantly improves health status at one year for patients suffering from symptomatic severe tricuspid regurgitation compared to medical therapy alone, according to trial results presented at Transcatheter Cardiovascular Therapeutics (TCT). The CLASP II TR trial evaluated 450 randomized patients to determine whether the device-based intervention outperformed conventional medication management alone.
CLASP II TR Trial Results Show Quality-of-Life Gains
The primary endpoint of the CLASP II TR trial encompassed all-cause mortality, right ventricular assist devices, heart transplants, tricuspid valve interventions, heart failure hospitalizations, and overall health status improvement on the Kansas City Cardiomyopathy Questionnaire (KCCQ). This composite produced a win ratio of 1.98 favoring the PASCAL device group with a 95% confidence interval between 1.47 and 2.67 and a p-value below 0.001, driven largely by patient-reported health score gains.
At six months, 38.8% of patients in the device group achieved survival paired with a large health status improvement, defined as a gain of 20 points or more on the KCCQ overall score. In contrast, only 12.3% of the control group reached that threshold. Similar divergence appeared among patients exhibiting moderate improvement of 10 points or more, with 57.1% of the PASCAL cohort reaching the mark versus 25.4% of patients receiving medical therapy alone.
Tricuspid Regurgitation Reduction and Safety Profiles at One Year
Anatomical success accompanied the quality-of-life findings. At the one-year mark, 79.9% of patients treated with the PASCAL system reduced their tricuspid regurgitation severity to moderate or less, compared to just 30.4% in the control arm. The PASCAL system received U.S. Food and Drug Administration approval for tricuspid valve repair in October 2026, building on a CE Mark granted in 2020.
Device intervention carried specific procedural risks. Data show that 20.1% of patients undergoing TTVr encountered a major adverse event within the study period, with severe bleeding standing as the most frequent complication at 8.5%. The CLASP II TR study represents one of five randomized evaluations examining tricuspid interventions, alongside the TRIC-I-HF study published in The New England Journal of Medicine.
Did you know about the PASCAL system’s design features?
According to Charles J. Davidson, Executive Vice Chair for Clinical Affairs, Department of Medicine, Northwestern University, Feinberg School of Medicine, the device features an elongation capability designed to prevent chordal entanglement, alongside atraumatic leaflet grasping to move through complex cardiac anatomies.
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Clinical Adoption Following FDA Approval
Medical centers have begun implementing the technology following federal clearance. The Naples Comprehensive Health (NCH) Rooney Heart Institute performed the nation’s first tricuspid valve repair using the Edwards Lifesciences PASCAL Precision system following the October 2026 regulatory approval. Robert Cubeddu led that procedure at the Florida facility, which served as a high-enrolling clinical trial site during the investigational phase prior to commercial clearance.
“These CLASP II TR results build upon an already established body of strong clinical evidence supporting the PASCAL system for tricuspid patients,” Charles J. Davidson said.
Frequently Asked Questions About the PASCAL System Trial
What was the primary endpoint of the CLASP II TR trial?
The primary endpoint evaluated a win ratio combining all-cause mortality, heart transplants, right ventricular assist device implantation, tricuspid valve re-intervention, heart failure hospitalizations, and score changes on the Kansas City Cardiomyopathy Questionnaire.
How did the PASCAL system affect patient mortality rates?
The trial showed no significant difference in overall mortality or heart failure hospitalizations between the device group and the control group receiving optimal medical therapy alone during the study period.
What regulatory milestones has the device achieved?
The PASCAL system secured a CE Mark in 2020 and subsequently received U.S. Food and Drug Administration approval for tricuspid valve repair in October 2026.