EFS of the CardioMech MVRS

Overview

About this study

The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥ 3+) or severe (≥ 4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Eighteen (18) years of age or greater

- Moderate to severe (≥ 3+) or severe (≥ 4+) mitral valve regurgitation (per American
Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail

- Intermediate or high surgical risk for mitral valve repair

Exclusion Criteria:

- History of rheumatic heart disease

- History of prior endocarditis

- History of prior repair or replacement of the mitral valve, annuloplasty or
valvuloplasty or has a left atrial appendage closure device

- Severely calcified mitral leaflet or has evidence of calcification in the grasping
area of the leaflets that would prevent leaflet anchor positioning and deployment

- Complex mechanism of MR (leaflet perforation, severe leaflet calcifications,
commissural extension, commissural prolapse, multiple flail or prolapsing segments,
cleft) present on required imaging

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/9/24. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Mayra Guerrero, M.D.	Open for enrollment	Contact information: Grace Bourassa (507) 255-5782 Bourassa.Grace@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mayra Guerrero, M.D.

Open for enrollment

Contact information:

Grace Bourassa

(507) 255-5782

Bourassa.Grace@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials