EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Polares Medical SA
Study ID
NCT07517588
Status
Recruiting
Apply to this trial

Conditions

  • Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MR-ace Implant and Delivery System — DEVICE
    This study device uses a transcatheter procedure through your leg veins to place the MRace implant and cover the posterior leaflet of your own mitral valve.

Study Details

The goal of this early feasibility clinical trial is to learn if the device MR-ace Implant and Delivery System works in patients with moderate or severe mitral valve regurgitation. It will also learn about the safety of the device MR-ace Implant and Delivery System. The main questions it aims to answer are: Does implanting the MR-ace device reduce the symptoms of mitral regurgitation? Does the device reduce the the leak through your mitral valve? Participants will: Be implanted with the device Visit the clinic for checkups and tests at 30 days, 6 months, 12 months, and 2, 3, 4 and 5 years following your procedure Complete a quality of life survey

Key Dates

First listed
Apr 8, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    treatment with the study device

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 30 days post procedure ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory MidtownAtlantaGeorgia30308
Elizabeth Charles
[email protected]
404-686-1249
Adam Greenbaum, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical CenterThe BronxNew York10467
Tammy Guzman
[email protected]
718-920-4595
Mohamad Latib, MD (PRINCIPAL_INVESTIGATOR)
The Lindner Research Center at The Christ HospitalCincinnatiOhio45219
Katy Fischesser
[email protected]
513-585-1777
Santiago Garcia, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By research site
Emory Midtown· Atlanta, GAMontefiore Medical Center· The Bronx, NYThe Lindner Research Center at The Christ Hospital· Cincinnati, OH

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