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PARADIGM and EXPLORE MR: TCT 2026 Research on PVL Closure and MR

Featured Clinical Research presented at TCT 2026 and simultaneously published in JACC: Cardiovascular Interventions adds to evidence assessing 30-day outcomes following transcatheter paravalvular leak (PVL) closure and posterior leaflet restoration (PLR) for secondary mitral regurgitation (MR), respectively.

Researchers involved with the PARADIGM study evaluated the Amplatzer Valvular Plug III (APVL3) for PVL closure after surgical implant of a mechanical or bioprosthetic valve in 200 patients from the U.S., Europe and Canada. Roughly 60% of participants were men, the average age was 67 and 70% had a mechanical valve.

Results found heart failure was the primary indication for PVL closure in nearly 90% of participants and 65% were treated for mitral PVL. Implantation was successful in the vast majority (96%) and no deaths were associated with the procedure. According to researchers, the 30-day procedural success was roughly 77%.

“PARADIGM met its primary endpoint, with favorable short-term outcomes,” said Ignacio Cruz-Gonzalez, MD, PhD, et al. “The results support this transcatheter device as a promising therapeutic option for PVL closure.”

Results from the EXPLORE MR study, found PLR using the MRace implant achieved substantial reduction in secondary MR and meaningful functional improvement, especially in patients without severely enlarged left ventricles.

Ulrich Schäfer, MD, et al., enrolled 78 symptomatic patients from Georgia and Brazil with severe secondary MR, to assess 30-day mortality, MR reduction and functional outcomes following deployment of the MRace implant. Of the participants, 32 had a severely enlarged left ventricle.

Overall, implantation was successful in approximately 96% of patients and all-cause mortality was 6.4% at 30 days. MR reductions were achieved in more than 90% of patients at 30 days and largely sustained at one year. Patients without severely enlarged left ventricles achieved even greater MR reductions at 30 days and one year, as well as better functional recovery and lower risk of all-cause mortality.

“These early feasibility results provide a foundation for future investigation of PLR as an alternative transcatheter strategy for patients with [secondary MR] and complex mitral valve anatomy who may be suboptimal candidates for conventional edge-to-edge repair,” note Schäfer and colleagues.

Explore more simultaneously published research through JACC Journals’ TCT 2026 Coverage, and visit ACC’s TCT Meeting Coverage for additional studies, clinical insights and news from the meeting.

Resources

Clinical Topics: Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Transcatheter Cardiovascular Therapeutics, TCT26, Mitral Valve, Heart Failure