TRISCEND II Pivotal Trial
Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
About this trial
This is an interventional treatment trial for Tricuspid Valve Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Symptomatic tricuspid regurgitation (TR) despite medical therapy
- TR graded as severe or greater
- Appropriate for transcatheter tricuspid valve replacement per the local heart team
Exclusion Criteria:
- Tricuspid valve anatomic contraindications
- 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
Sites / Locations
- SJHMC Heart and Vascular InstituteRecruiting
- Tucson Medical CenterRecruiting
- Scripps Memorial Hospital La JollaRecruiting
- Cedars-Sinai Medical CenterRecruiting
- UC Davis Medical CenterRecruiting
- Kaiser Permanente San FranciscoRecruiting
- University of California San FranciscoRecruiting
- Stanford UniversityRecruiting
- Medical Center of the Rockies
- Florida Heart & Vascular Care - JFKRecruiting
- The Cardiac & Vascular Institute Research FoundationRecruiting
- NCH Heart InstituteRecruiting
- Emory UniversityRecruiting
- Piedmont Heart InstituteRecruiting
- Northwestern UniversityRecruiting
- St. Vincent Heart Center of IndianaRecruiting
- Kansas University Medical CenterRecruiting
- Cardiovascular Research Institute of KansasRecruiting
- University of MarylandRecruiting
- Johns Hopkins Hospital
- Massachusetts General HospitalRecruiting
- Brigham and Women's HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of Michigan Hospital and Health SystemsRecruiting
- Henry Ford Health SystemRecruiting
- Mayo ClinicRecruiting
- Saint Luke's Hospital of Kansas CityRecruiting
- Washington University Barnes-Jewish Hospital
- Morristown Medical CenterRecruiting
- Rutgers Robert Wood Johnson Medical SchoolRecruiting
- Montefiore Medical CenterRecruiting
- State University of New York at BuffaloRecruiting
- North Shore University HospitalRecruiting
- NYU Langone HealthRecruiting
- Weill Cornell Medicine-New York Presbyterian HospitalRecruiting
- Columbia University Medical Center/NYPHRecruiting
- Lenox Hill HospitalRecruiting
- Rochester General Hospital
- St. Francis HospitalRecruiting
- University of North Carolina - Chapel HillRecruiting
- Carolinas Medical CenterRecruiting
- The Christ HospitalRecruiting
- Cleveland ClinicRecruiting
- Oklahoma Heart InstituteRecruiting
- Oregon Health & Science UniversityRecruiting
- University of PennsylvaniaRecruiting
- Lankenau Heart InstituteRecruiting
- Saint Thomas HealthRecruiting
- Vanderbilt University Medical CenterRecruiting
- HCA Houston HealthcareRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- Baylor Heart Hopsital PlanoRecruiting
- Intermountain Medical CenterRecruiting
- University of Virginia Health SystemRecruiting
- Sentara Norfolk General HospitalRecruiting
- Virginia Mason Franciscan HealthRecruiting
- Swedish Medical CenterRecruiting
- University of WashingtonRecruiting
- Herz- und Diabeteszentrum NRW, Bad Oeynhausen
- Herzzentrum Universitätsklinik Bonn
- Herzzentrum Dresden Universitätsklinik
- Herzzentrum der Uniklinik Köln
- Herzzentrum Leipzig GmbH
- Johannes Gutenberg-Universität Mainz
- Klinikum der Universität München - Großhadern
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Experimental
Edwards EVOQUE System & OMT
Optimal Medical Therapy (OMT)
Single-Arm Registry
Continued Access Study
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.