Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair (ReChord)
Primary Purpose
Mitral Valve Insufficiency
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeoChord DS1000
Surgical Mitral Valve Repair
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Degenerative, Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Is a candidate for mitral valve repair with cardiopulmonary bypass
- Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
- Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
- Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
- Anatomic and general suitability
Exclusion Criteria:
- Prior mitral valve surgery
- Concomitant cardiac procedures
- Other cardiac procedures within 3 months
Sites / Locations
- Sutter Health/Alta Bates Summitt Medical CenterRecruiting
- Mercy General HospitalRecruiting
- Stanford UniversityRecruiting
- MedStar Washington Hospital CenterRecruiting
- Florida Hospital
- Piedmont Heart InstituteRecruiting
- Franciscan HealthRecruiting
- Johns Hopkins UniversityRecruiting
- University of MichiganRecruiting
- Mount Sinai, Icahn School of MedicineRecruiting
- Columbia University Medical CenterRecruiting
- The Christ Hospital
- Pinnacle HealthRecruiting
- Penn State Milton S. Hershey Medical Center
- University of Pittsburgh Medical CenterRecruiting
- St. ThomasRecruiting
- Baylor - PlanoRecruiting
- Valley Health System | VirginiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment Group
Control Group
Arm Description
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
Outcomes
Primary Outcome Measures
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02803957
Brief Title
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
Acronym
ReChord
Official Title
Randomized Trial of the NeoChord™ DS1000™ System Versus Open Surgical Repair
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2016 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeoChord
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
Keywords
Degenerative, Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
585 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
Intervention Type
Device
Intervention Name(s)
NeoChord DS1000
Intervention Description
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Intervention Type
Device
Intervention Name(s)
Surgical Mitral Valve Repair
Intervention Description
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
Primary Outcome Measure Information:
Title
Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group.
Time Frame
Post-operative Day (POD) 30
Title
Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is a candidate for mitral valve repair with cardiopulmonary bypass
Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation
Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram
Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement
Anatomic and general suitability
Exclusion Criteria:
Prior mitral valve surgery
Concomitant cardiac procedures
Other cardiac procedures within 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David H Adams, MD
Phone
212-659-6820
Email
david.adams@mountsinai.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Borger, MD, Ph.D.
Phone
+49-341-865-1421
Email
Michael.Borger@helios-kliniken.de
Facility Information:
Facility Name
Sutter Health/Alta Bates Summitt Medical Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junaid Khan, MD
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frank Slachman, MD
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jack Boyd, MD
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Shults, MD
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Withdrawn
Facility Name
Piedmont Heart Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederico Milla, MD
Facility Name
Franciscan Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Gerdisch, MD
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Shena, MD
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Romano, MD
Facility Name
Mount Sinai, Icahn School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David H Adams, MD
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isaac George, MD
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Withdrawn
Facility Name
Pinnacle Health
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mubashir Mumtaz, MD
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Gleason, MD
Facility Name
St. Thomas
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelio Rodriguez, MD
Facility Name
Baylor - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Smith, MD
Facility Name
Valley Health System | Virginia
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Basel Ramlawi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
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