Regulatory Approval

Edwards awaits FDA call on PASCAL for tricuspid regurgitation as pivotal trial keeps enrolling

Edwards expects a Q4 2026 FDA decision on PASCAL for tricuspid regurgitation, but the pivotal CLASP II TR trial's own completion date runs to December 2027, after a 46% enrollment target increase.

By AppliedXLJuly 13, 2026Trial NCT04097145

Executive Summary

Edwards has told investors to expect FDA approval of PASCAL in tricuspid regurgitation within a specific quarter this year, a concrete regulatory milestone the company has chosen to disclose ahead of time.
The pivotal trial backing this indication is still recruiting and its own registered completion date runs well past the guided approval window, raising the question of what evidence Edwards is submitting now.
The trial's target patient count has grown substantially since last spring even as its completion timeline has already slipped multiple times since the study began, a pattern that shapes how much of the pivotal data set will inform this specific decision.
Approval would land in a tricuspid regurgitation device field that is active but mechanistically diverse, with several rival transcatheter systems still in earlier pivotal stages and none yet established as a validated benchmark therapy.

The guidance

Edwards Lifesciences disclosed at its December 4, 2025 investor conference that it expects FDA approval of PASCAL for tricuspid regurgitation (TR) in the fourth quarter of 2026. The company's CEO, Bernard Zovighian, framed the broader structural heart push at that conference around indication expansion and evidence generation, telling investors Edwards is targeting patient groups "currently unaddressed today," including those with tricuspid or aortic regurgitation needing a transcatheter option. PASCAL already sits inside Edwards' TMTT (transcatheter mitral and tricuspid therapies) portfolio alongside EVOQUE and SAPIEN M3, a unit the company separately guided to $740 million to $780 million in 2026 sales. Edwards

The pivotal trial

The clinical evidence tied to this approval traces to NCT04097145, Edwards' CLASP II TR pivotal trial, which is registered as Recruiting with a target enrollment of 1,270 patients across the United States and Canada. The trial's primary completion date is registered as December 31, 2027, a year past the close of the guided approval window. The primary outcome is a composite of all-cause mortality, right ventricular assist device implantation or heart transplant, tricuspid valve intervention, heart failure hospitalization, and quality-of-life improvement measured by KCCQ score. NCT04097145

How the trial got here

CLASP II TR started enrolling in December 2019, and its primary completion date has moved three times since: from August 2022 to December 2024 in April 2022, to December 31, 2024 in June 2023, and then out to December 31, 2027 in November 2024, a cumulative delay of more than three years from the original target. Enrollment was raised from 825 to 870 patients in June 2023 and then to 1,270 patients in May 2026, a 46% increase from the prior target. The trial has also cycled through status changes, briefly listed as Withheld for two days in October 2020 before returning to Recruiting. NCT04097145

The competitive field

Tricuspid regurgitation device development is active but not yet anchored by a single validated mechanism: competing transcatheter systems from TRiCares, Jenscare Innovation, VDyne, and Cardiovalve are each in earlier pivotal or not-yet-recruiting stages, and none has produced a resolved regulatory outcome that establishes a benchmark for this class. Edwards' own PASCAL trial carries the largest enrollment target among these active TR device programs at 1,270 patients. No FDA approval history for PASCAL could be independently confirmed, and no regulatory designation (such as Breakthrough Therapy or Priority Review) for this program surfaced in the search performed.

Sponsor context

Edwards Lifesciences has completed 34 of 42 tracked trials, with 8 terminated, an 81% completion rate across its broader portfolio. That track record situates PASCAL's regulatory path within a sponsor with more completions than terminations, though it does not resolve what specific data package this particular submission rests on given the trial's own registered timeline.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.