Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
572 participants
INTERVENTIONAL
2019-08-21
2029-04-30
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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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Randomized - Device Group
Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
TriClipTM Device
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
Randomized - Control Group
Subjects will continue to be managed on medical therapy, per physician discretion
TriClipTM Device
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
Single Arm Group
Subjects will receive the TriClip device and will continue to be managed on medical therapy, per physician discretion.
TriClipTM Device
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
Continued Access Study (CAS)
Subjects will undergo TriClip implantation and will continue to be managed on medical therapy, per physician discretion
TriClipTM Device
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
Interventions
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TriClipTM Device
Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
Eligibility Criteria
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Inclusion Criteria
* Optimized medical therapy for treatment of TR (e.g. diuretics).
* Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
* The Eligibility Committee will confirm that the subject has been adequately treated medically.
* Subject is symptomatic with Severe TR despite being optimally treated as described above. TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s).
* The cardiac surgeon of the site local heart team concur that the patient is at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
* New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
* In the judgment of the TriClip(TM) implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.
* Age ≥18 years at time of consent.
* Subject must provide written informed consent prior to any trial related procedure.
Exclusion Criteria
* Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
* Any prior tricuspid valve procedure that would interfere with placement of the TriClip(TM) device
* Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial.
* Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM) clip.
* Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL
* Left Ventricular Ejection Fraction (LVEF) ≤20%
* Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
* Evidence of calcification in the grasping area
* Presence of a severe coaptation defect (\> 2cm) of the tricuspid leaflets
* Severe leaflet defect(s) preventing proper device placement
* Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle.
* Tricuspid valve anatomy not evaluable by TTE and TEE
* Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated).
* MI or known unstable angina within prior 30 days
* Percutaneous coronary intervention within prior 30 days
* Hemodynamic instability defined as systolic pressure \< 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
* Cerebrovascular Accident (CVA) within prior 90 days
* Chronic dialysis
* Bleeding disorders or hypercoagulable state
* Active peptic ulcer or active gastrointestinal (GI) bleeding
* Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
* Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.
* Ongoing infection requiring current antibiotic therapy (if temporary illness, patients may enroll 30 days after discontinuation of antibiotics with no active infection).
* Known allergy or hypersensitivity to device materials
* Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
* Life expectancy of less than 12 months
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
* Subject is currently participating in another clinical investigation for valvular heart disease(s).
* Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. Female subjects of child-bearing potential are required to have a negative pregnancy test done within 7 days of the baseline visit per site standard test. Female patients of childbearing potential should be instructed to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.) It is accepted, in certain cases, to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method.
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
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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Meghan Griffin, PhD
Role: STUDY_DIRECTOR
Abbott Structural Heart
David Adams, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Paul Sorajja, MD
Role: PRINCIPAL_INVESTIGATOR
Allina Health System
Locations
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University Hospital - University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Scottsdale Healthcare Shea
Scottsdale, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
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
Providence Medical Foundation (St. Joseph Hospital)
Orange, California, United States
Sutter Medical Center, Sacramento
Sacramento, California, United States
University of California - Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven
New Haven, Connecticut, United States
JFK Medical Center
Atlantis, Florida, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Morton Plant Valve Clinic
Clearwater, Florida, United States
Delray Medical Center
Delray Beach, Florida, United States
Baptist Hospital of Miami
Miami, Florida, United States
Palm Beach Garden Medical Center
Palm Beach Gardens, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University HealthSystem
Evanston, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
MedStar Health Research Institute
Hyattsville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Albany Medical Center
Albany, New York, United States
Buffalo General Hospital
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
New York-Presbyterian/Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center - Moses Division
The Bronx, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Novant Health Heart and Vascular Research Institute
Charlotte, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Centennial Heart Cardiovascular Consultants
Nashville, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Austin Heart
Austin, Texas, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, United States
The Methodist Hospital
Houston, Texas, United States
Methodist Hospital of San Antonio
San Antonio, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
St. Paul's Hospital
Vancouver, British Columbia, Canada
Hamilton Health Science Centre
Hamilton, Ontario, Canada
Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
The Royal Victoria
Montreal, Quebec, Canada
München Grosshadern
München, Bavaria, Germany
Universitätsklinikum Bonn AdöR
Bonn, North Rhine-Westphalia, Germany
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Herzzentrum Leipzig GmbH
Leipzig, Saxony, Germany
Ospedale San Raffaele - Cardiac
Milan, Lombard, Italy
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia, Spain
Countries
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References
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Kar S, Makkar RR, Whisenant BK, Hamid N, Naik H, Tadros P, Price MJ, Singh G, Schwartz JG, Kapadia S, Alli O, Horr S, Seshiah P, Batchelor W, Jones BM, Ahmed MI, Benza R, Jorde U, Thourani VH, Ghobrial AA, Tang GHL, Trusty PM, Huang D, Hahn RT, Adams DH, Sorajja P; TRILUMINATE Pivotal Investigators. Two-Year Outcomes of Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation: The TRILUMINATE Pivotal Randomized Controlled Trial. Circulation. 2025 Jun 10;151(23):1630-1638. doi: 10.1161/CIRCULATIONAHA.125.074536. Epub 2025 Mar 30.
Naik H, Price MJ, Kapadia S, Whisenant BK, Tadros P, Makkar R, Asgar AW, Fam N, Tang GHL, Mehta SR, Byrne T, Singh G, Panaich SS, Peterman K, Trusty PM, Hamid N, Hahn RT, Adams DH, Sorajja P. Tricuspid Transcatheter Edge-to-Edge Repair in Patients With Transvalvular CIED Leads: The TRILUMINATE Pivotal Trial. JACC Clin Electrophysiol. 2025 May;11(5):1012-1020. doi: 10.1016/j.jacep.2025.01.001. Epub 2025 Jan 20.
Cavalcante JL, Scherer M, Fukui M, Lerakis S, Harb S, Pursnani A, Schwartz JG, Kapadia S, Ricciardi MJ, Khalique O, Kodali S, Shah D, Little SH, Sekaran N, Whisenant B, Flueckiger P, Yadav P, Emaminia A, Batchelor W, Kellman P, Lin Z, Trusty PM, Hahn RT, Adams D, Sorajja P. Advanced Imaging Assessment of the Impact of Tricuspid Regurgitation on Cardiac Remodeling: The TRILUMINATE Pivotal Imaging Substudy. J Am Coll Cardiol. 2025 Jan 28;85(3):250-261. doi: 10.1016/j.jacc.2024.09.009. Epub 2024 Nov 20.
Jorde UP, Benza R, McCarthy PM, Ailawadi G, Whisenant B, Makkar R, Tadros P, Naik H, Fam N, Sauer AJ, Murthy S, Kar S, von Bardeleben RS, Hahn RT, Hamid N, Zbinden J, Sorajja P, Adams D. Impact of Renal and Liver Function on Clinical Outcomes Following Tricuspid Valve Transcatheter Edge-to-Edge Repair. J Am Coll Cardiol. 2024 Dec 17;84(25):2446-2456. doi: 10.1016/j.jacc.2024.08.044. Epub 2024 Aug 31.
Sorajja P, Whisenant B, Hamid N, Naik H, Makkar R, Tadros P, Price MJ, Singh G, Fam N, Kar S, Schwartz JG, Mehta S, Bae R, Sekaran N, Warner T, Makar M, Zorn G, Spinner EM, Trusty PM, Benza R, Jorde U, McCarthy P, Thourani V, Tang GHL, Hahn RT, Adams DH; TRILUMINATE Pivotal Investigators. Transcatheter Repair for Patients with Tricuspid Regurgitation. N Engl J Med. 2023 May 18;388(20):1833-1842. doi: 10.1056/NEJMoa2300525. Epub 2023 Mar 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ABT-CIP-10249
Identifier Type: -
Identifier Source: org_study_id