Clinical trial NCT04820764: EFS of the CardioMech MVRS
Official title: Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: CardioMech AS
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
timeFrame: 30 days
measure: Change in MR grade
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Thousand Oaks
country: United States
facility: Cardiovascular Institute of Los Robles Health System
state: California
city: Wichita
country: United States
facility: Ascension St. Francis via Christi
state: Kansas
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Cloud
country: United States
facility: CentraCare Heart & Vascular Center
state: Minnesota
city: New York City
country: United States
facility: NYU Langone
state: New York
city: Charlotte
country: United States
facility: Atrium Health Sanger Heart and Vascular Institute
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Nashville
country: United States
facility: Ascension St. Thomas West
state: Tennessee
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: NYU Langone
name: Mathew Williams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Mayra Guerrero, MD
role: PRINCIPAL_INVESTIGATOR
References: