Early Feasibility EXperience of Posterior Leaflet RestOration to REduce Mitral Regurgitation (EXPLORE MR)

Polares Medical SA3 sites in 2 countries2 target enrollmentJanuary 1, 2020

Overview

Early feasibility study, single-arm registry design

First-In-Human

Registry

clinicaltrials.gov

Start Date

January 1, 2020

End Date

February 2, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•18 years of age or older.
•Greater than moderate degenerative or functional mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure
•Patient must present with an STS Score less than 10%
•High surgical risk for conventional mitral repair or replacement due to morphological criteria (e.g. leaflet or annulus calcifications) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
•Mitral valve anatomy deemed unsuitable to be treated with an approved edge-to-edge repair system (e.g., retracted posterior leaflet, lack of leaflet tissue, calcified or cleft posterior leaflet) as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure
•Patient is approved by an independent Patient Eligibility Committee
•New York Heart Association (NYHA) Functional Class III or IV
•Patient willing to participate in study and provide signed EC-approved informed consent.
•Treating physician and patient agree that patient is able to return for all required post- procedure follow-up visits
•Women of child-bearing potential have a negative pregnancy test

Primary safety endpoint

Time Frame: 30 days

All-cause mortality

Improvement from baseline mitral regurgitation

Time Frame: 30 days

Grade 2+ or less as evaluated by 2D transthoracic echocardiography

Procedure success according to MVARC2 criteria(30 days)
Technical success according to MVARC2 criteria(24 hours)
Device success according to MVARC2 criteria(30 days, 6 and 12 months, and 2 - 5 years post treatment)
Patient success according to MVARC2 criteria(30 days, 6 and 12 months, and 2 - 5 years post treatment)
Rate (%) of major adverse events as defined by MVARC2 criteria(Procedure, discharge/7 days, 30 days, 6 and 12 months, and 2 - 5 years post treatment)