Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair
NCT ID: NCT02803957
Last Updated: 2019-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
585 participants
INTERVENTIONAL
2016-11-03
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Group
Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000
NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Control Group
Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair
Surgical Mitral Valve Repair
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
Interventions
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NeoChord DS1000
Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
Surgical Mitral Valve Repair
Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
Eligibility Criteria
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Inclusion Criteria
* 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
* Concomitant cardiac procedures
* Other cardiac procedures within 3 months
21 Years
ALL
No
Sponsors
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NeoChord
INDUSTRY
Responsible Party
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Locations
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Sutter Health/Alta Bates Summitt Medical Center
Oakland, California, United States
Mercy General Hospital
Sacramento, California, United States
Stanford University
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Franciscan Health
Indianapolis, Indiana, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Mount Sinai, Icahn School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
St. Thomas
Nashville, Tennessee, United States
Baylor - Plano
Plano, Texas, United States
Valley Health System | Virginia
Winchester, Virginia, United States
Countries
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Central Contacts
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Other Identifiers
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NeoChord: PR-610405-100
Identifier Type: -
Identifier Source: org_study_id
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