Clinical Trial

EXPLORE FMR: Early Feasibility Study of the PLAR Implant and Delivery System to Treat Functional Mitral Regurgitation

Withdrawn
View on ClinicalTrials.gov →
Why the trial stopped
product refinement
Summary
An early feasibility study to evaluate the safety and feasibility of the PLAR Implant and Delivery System to treat severe functional mitral regurgitation and to gather preliminary data on its performance thereby providing guidance for future clinical development. The study is a single-arm registry with the last follow-up visit at 5 years post-intervention. The study will enroll up to 10 patients at one (1) center in Brazil.
Protocol Amendment History 3 changes
critical Withdrawn before enrolling 2026-08-11
critical Trial withdrawn: product refinement 2026-08-11
notable Enrollment reduced: 10 -> 0 participants 2026-08-11
Trial Details
NCT Number NCT04679714
Lead Sponsor Polares Medical SA
Collaborators: Polares Medical, Inc.
Conditions Functional Mitral Regurgitation
Start Date 2021-04-30
Primary Completion 2022-03 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-10