Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
228 participants
INTERVENTIONAL
2020-05-06
2029-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System
Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Interventions
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Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic despite medical therapy or prior HF hospitalization from TR
* The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
Exclusion Criteria
* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
* Hemodynamic instability
* Refractory heart failure requiring advanced intervention
* Currently participating in another investigational study in which the patient has not reached a primary endpoint
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Susheel Kodali, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern University
Evanston, Illinois, United States
Massachusetts General Hospital Boston
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Columbia University Irving Medical Center / NYPH
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor Heart Hopsital Plano
Plano, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
St. Paul's Hospital Vancouver
Vancouver, British Columbia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
Québec, , Canada
CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
Pessac, , France
Clinique Pasteur
Toulouse, , France
InselSpital University Hospital Bern
Bern, , Switzerland
Countries
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References
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Kodali S, Hahn RT, Makkar R, Makar M, Davidson CJ, Puthumana JJ, Zahr F, Chadderdon S, Fam N, Ong G, Yadav P, Thourani V, Vannan MA, O'Neill WW, Wang DD, Tchetche D, Dumonteil N, Bonfils L, Lepage L, Smith R, Grayburn PA, Sharma RP, Haeffele C, Babaliaros V, Gleason PT, Elmariah S, Inglessis-Azuaje I, Passeri J, Herrmann HC, Silvestry FE, Lim S, Fowler D, Webb JG, Moss R, Modine T, Lafitte S, Latib A, Ho E, Goldberg Y, Shah P, Nyman C, Rodes-Cabau J, Bedard E, Brugger N, Sannino A, Mack MJ, Leon MB, Windecker S; the TRISCEND study investigators. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023 Dec 7;44(46):4862-4873. doi: 10.1093/eurheartj/ehad667.
Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-06
Identifier Type: -
Identifier Source: org_study_id
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