Back to resultsEFS of the CardioMech MVRS
Primary Purpose
Mitral Regurgitation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CardioMech MVRS
Sponsored by
About this trial
This is an interventional device feasibility trial for Mitral Regurgitation
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, 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
Sites / Locations
- Ascension St. Francis via Christi
- Mayo Clinic
- NYU Langone
- Atrium Health Sanger Heart and Vascular Institute
- Ascension St. Thomas West
- Intermountain Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CardioMech Mitral Valve Repair System (MVRS)
Arm Description
Outcomes
Primary Outcome Measures
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Change in MR grade
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04820764
Brief Title
EFS of the CardioMech MVRS
Official Title
Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CardioMech AS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CardioMech Mitral Valve Repair System (MVRS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CardioMech MVRS
Intervention Description
CardioMech MVRS
Primary Outcome Measure Information:
Title
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Time Frame
30 days
Title
Change in MR grade
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathew Williams, MD
Organizational Affiliation
NYU Langone
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mayra Guerrero, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension St. Francis via Christi
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Atrium Health Sanger Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Ascension St. Thomas West
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
EFS of the CardioMech MVRS
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