An early feasibility study to evaluate the safety and feasibility of the MRace Implant and Delivery System to treat severe 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.
18 years of age or older
Greater than moderate 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), but operable, 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
Severe tricuspid regurgitation
Severe aortic stenosis or insufficiency
Severe mitral annulus calcification
Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification
Single group
Transcatheter mitral valve repair (MRace Implant and Delivery System)
DeviceThe MRace Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture Other Names: TMVr
Incidence of all-cause mortality following treatment with the MRace Implant and Delivery System
Primary safety outcome
Incidence of change from severe mitral regurgitation at baseline (Grade 3+ or more) to moderate or less mitral regurgitation (Grade 2+ or less) following treatment with the MRace Implant and Delivery System as evaluated by 2D TTE
Primary performance endpoint
Rate of major safety events as defined by MVARC2 definitions
Secondary safety endpoint
Technical success rate per MVARC2 definitions
All of the following must be present for technical success: Absence of procedure mortality Successful access, delivery and retrieval of investigation delivery system Successful deployment and correct positioning of intended implant(s) Freedom from emergency surgery/re-intervention related to device or access procedure
Procedure success rate per MVARC2 definitions
Both of the following must be present for procedure success: Device success Absence of major device or procedure-related serious adverse events as below: Death Stroke Life-threatening bleed Major vascular complication Major cardiac structural complication Stage 2 or 3 AKI MI or coronary ischemia requiring PCI or CABG Shock, heart or respiratory failure requiring IV vasopressors, mechanical intervention or prolonged intubation Valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
Device success rate per MVARC 2 definitions
All of the following must be present for device success: Absence of procedure mortality or stroke Proper placement and positioning of device Freedom from unplanned re-intervention related to device or access procedure Continued intended safety and performance of the device as below: No evidence of structural or functional failure No device technical failure issues/complications MR reduction to moderate or less without stenosis
Click on the lead sponsor to view all of their trials.
Polares Medical SA
Lead sponsor
Polares Medical, Inc.
Collaborator
