EFS of the CardioMech MVRS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CardioMech MVRS.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Overview
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
- Device CardioMech MVRS
CardioMech MVRS
Primary outcome measures
- Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure [Time frame: 30 days]
- Change in MR grade [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Device feasibility
Study locations
United States · 12 centers
- Cardiovascular Institute of Los Robles Health System — Thousand Oaks
- Northwestern University — Evanston
- Ascension St. Francis via Christi — Wichita
- Mayo Clinic — Rochester
- CentraCare Heart & Vascular Center — Saint Cloud
- NYU Langone — New York
- Atrium Health Sanger Heart and Vascular Institute — Charlotte
- The Christ Hospital — Cincinnati
- … and 4 more centers
Identifiers
NCT: NCT04820764 · 10228