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
250 participants
INTERVENTIONAL
2023-10-16
2027-06-30
Brief Summary
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Detailed Description
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This mechanistic ancillary study has the following aims:
1. To compare the impact of MVr and TEER on disordered ventricular biomechanics and myocardial fibrosis that predispose to ventricular arrhythmias, using speckle tracking strain echocardiography, cardiac magnetic resonance imaging (CMR), and rhythm monitoring pre- and post-mitral valve (MV) intervention. The research team hypothesize's that a treatment strategy that more effectively and durably reduces MVP and MR will lead to improved ventricular mechanics, limit progression of myocardial fibrosis and decrease the burden of ventricular arrhythmias and HF.
2. To compare the impact of MVr and TEER on recurrent/residual MR, LV and left atrial (LA) reverse remodeling with baseline and 1-year post-intervention CMR, and to use quantitative CMR myocardial tissue phenotyping as a predictor of response to MVr and TEER.
3. To construct functional pre-operative CMR fingerprints that recapitulate the mechanical state of the heart to develop individualized computational models, which will be altered in silico based on the proposed treatment plan, to predict patients' response to therapy. These results will be validated against post-operative outcome data to test the validity of this approach for predicting treatment response.
4. To explore the relationships among gene products, structural variables, and post-operative clinical outcomes, including reverse remodeling, using tissue obtained at surgery from ventricular myocardium.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Mitral valve repair
Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance.
Cardiac Magnetic Resonance Imaging
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch Monitoring
ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.
Myocardial Tissue Biopsy
During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.
Transcatheter edge-to-edge repair
Patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Cardiac Magnetic Resonance Imaging
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch Monitoring
ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.
Interventions
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Cardiac Magnetic Resonance Imaging
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch Monitoring
ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.
Myocardial Tissue Biopsy
During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
Exclusion Criteria
* Prior adverse reaction to gadolinium administration.
* Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
* Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).
60 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Annetine Gelijns
OTHER
Responsible Party
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Annetine Gelijns
Department Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR
Principal Investigators
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Joanna Chikwe, MD
Role: STUDY_DIRECTOR
Cedars-Sinai
Martin Leon, MD
Role: STUDY_DIRECTOR
Columbia University
Locations
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Keck Hospital of the University of Southern California
Los Angeles, California, United States
Cedars-Sinai
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Maine Medical Center
Portland, Maine, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, United States
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Deutsches Herzzentrum der Charité
Berlin, , Germany
Herzzentrum Leipzig
Leipzig, , Germany
Royal Papworth Hospital NHS Foundation Trust
Trumpington, Cambridge, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
Barts Health NHS Trust
Whitechapel, London, United Kingdom
Manchester University NHS Foundation Trust
Oxford, Manchester, United Kingdom
South Tees Hospitals NHS Foundation Trust
Marton-in-Cleveland, Middlesbrough, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Zyriah Robinson
Role: primary
Related Links
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PRIMARY Trial
Other Identifiers
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GCO 08-1078 ANC
Identifier Type: -
Identifier Source: org_study_id
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