Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional MR
NCT ID: NCT07227675
Last Updated: 2025-11-13
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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COMPLETED
NA
162 participants
INTERVENTIONAL
2017-10-23
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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The MitraClip NT Device
The MitraClip NT System comprises the MitraClip NT Clip Delivery System
MitraClip® NT System
The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR
Interventions
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MitraClip® NT System
The MitraClip NT System is intended to treat heart failure patients with symptomatic ischemic or non-ischemic functional MR
Eligibility Criteria
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Inclusion Criteria
* Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology
* Subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure
* Subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP ≥300 pg/ml or corrected NT-proBNP ≥1500 pg/ml
* New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
* Surgery will not be offered as a treatment option and medical therapy is the intended therapy for the subject
* Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50%
* Left Ventricular End Systolic Dimension (LVESD) is ≤70 mm
Exclusion Criteria
* Coronary artery bypass grafting (CABG) within prior 30 days
* Percutaneous coronary intervention within prior 30 days
* Tricuspid valve disease requiring surgery
* Aortic valve disease requiring surgery
* Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
* Cerebrovascular accident within prior 30 days
* Severe symptomatic carotid stenosis (\> 70% by ultrasound)
* Carotid surgery within prior 30 days
* Mitral valve orifice area \< 4.0 cm2
* Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
William T Abraham, MD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University Heart Center
JoAnn Lindenfeld, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Gregg W Stone,, MD
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Scripps Green Hospital
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
El Camino Hospital
Mountain View, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
University of Colorado Hospital
Denver, Colorado, United States
Mount Sinai Medical Center
Miami, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Piedmont Hospital Atlanta
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center / New York Presbyterian Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States
Seton Medical Center Austin
Austin, Texas, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
The heart hospital baylor plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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11- 512
Identifier Type: -
Identifier Source: org_study_id