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EFS of the CardioMech MVRS

Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04820764
Enrollment
25
Registered
2021-03-29
Start date
2021-07-27
Completion date
2031-09-01
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Brief summary

Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.

Detailed description

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.

Interventions

DEVICECardioMech MVRS

CardioMech MVRS

Sponsors

CardioMech AS
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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, or annuloplasty * 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

Design outcomes

Primary

MeasureTime frame
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure30 days
Change in MR grade30 days

Countries

United States

Contacts

CONTACTJennifer Ruether
jennifer.ruether@cardiomech.com651-248-4440
CONTACTRick Nehm
rick.nehm@cardiomech.com
PRINCIPAL_INVESTIGATORMathew Williams, MD

NYU Langone

PRINCIPAL_INVESTIGATORMayra Guerrero, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026