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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ACTIVE_NOT_RECRUITING
NA
1070 participants
INTERVENTIONAL
2021-04-09
2030-06-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Edwards EVOQUE System & OMT
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Optimal Medical Therapy
Optimal Medical Therapy
Single-Arm Registry
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
Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Continued Access Study
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.
Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Interventions
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Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Optimal Medical Therapy
Optimal Medical Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Despite medical therapy (OMT) per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR. Patient must be on OMT per the local heart team at the time of TR assessment for trial eligibility (TTE). OMT includes stable oral diuretic medications, unless patient has a documented history of intolerance.
* Functional and/or degenerative TR graded as at least severe on a transthoracic echocardiogram (assessed by the echo core lab using a 5-grade classification)
* The Local Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
* Patient is willing and able to comply with all study evaluations and provides written informed consent.
Exclusion Criteria
* LVEF \< 25%
* Evidence of severe right ventricular dysfunction
* Any of the following pulmonary pressure parameters:
1. PASP \>60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
2. PASP \>70 mmHg by RHC
3. PVR \>5 Wood units by RHC (unless PVR ≤5 Wood units and systolic BP \>85 mmHg after vasodilator challenge)
* Previous tricuspid surgery or intervention
* Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:
1. Implanted in the RV within the last90 days
2. Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
3. Has delivered appropriate ICD therapy
* Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation.
* Active endocarditis within the last 90 days or infection requiring antibiotic therapy (oral or intravenous) within the last 14 days
* Hemodynamically significant pericardial effusion
* Significant intra-cardiac mass, thrombus, or vegetation.
* Clinically significant, untreated coronary artery disease requiring revascularization, evidence of acute coronary syndrome, recent myocardial infarction within the last 30 days.
* Any of the following cardiovascular procedures:
1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
2. Carotid surgery within the last 30 days
3. Direct current cardioversion within the last 30 days
4. Leadless RV pacemaker implant within the last 30 days
5. Cardiac surgery within the last 90 days
* Known history of untreated severe symptomatic carotid stenosis (\>50% by ultrasound) or asymptomatic carotid stenosis (\>70% by ultrasound)
* Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365days), or any planned percutaneous cardiac procedure within the next 90 days
* Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or hemodynamic support within the last 30 days
* Patient with refractory heart failure requiring or which required advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA/ESC/EACTS Stage D heart failure)
* Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 6 months (180 days)
* Stroke within the last 90 days
* Modified Rankin Scale ≥ 4 disability
* Severe renal insufficiency with estimated glomerular filtration rate (eGFR) ≤ 25 mL/min/1.73m2 or requiring chronic renal replacement therapy.
* Patients with hepatic insufficiency or cirrhosis with Child-Pugh score class C
* Patient is oxygen-dependent or requires continuous home oxygen
* Chronic anemia with transfusion dependency or Hgb \< 9 g/dL not corrected by transfusion
* Unable to walk at least 100 meters in a 6-minute walk test
* Thrombocytopenia (Platelet count \< 75,000/mm3) or thrombocytosis (Platelet count \> 750,000/mm3)
* Known bleeding or clotting disorders or patient refuses blood transfusion
* Active gastrointestinal (GI) bleeding within the last 90 days
* Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days).
* Patients in whom (any of the following):
1. TEE is contraindicated or cannot be completed
2. tricuspid valve anatomy is not evaluable by TTE or TEE
* In the opinion of the investigator, access to and through the femoral vein/IVC with a guide sheath and delivery catheter is deemed not feasible (e.g. occluded femoral veins, occluded or thrombosed IVC filter)
* Untreatable hypersensitivity or contraindication to any of the following: all antiplatelets, all anticoagulants, nitinol alloys (nickel and titanium), bovine tissue, glutaraldehyde, or contrast media
* Currently participating in another investigational biologic, drug or device study
* Co-morbid condition(s) that, in the opinion of the Investigator, limit life expectancy to \< 12 months (365 days).
* Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant uncorrected congenital heart disease (including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV)
* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-ups
* Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
* Any patient considered to be vulnerable
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Hahn, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Susheel Kodali, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Philipp Lurz, MD
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum Leipzig GmbH
Vinod Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Heart Institute
Locations
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SJHMC Heart and Vascular Institute
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UC Davis Medical Center
Sacramento, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Florida Heart & Vascular Care - JFK
Atlantis, Florida, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
NCH Heart Institute
Naples, Florida, United States
Emory University
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Ascension Via Christi St. Francis
Wichita, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
State University of New York at Buffalo
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Heart Institute
Wynnewood, Pennsylvania, United States
Saint Thomas Health
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
HCA Houston Healthcare
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Baylor Heart Hopsital Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Mason Franciscan Health
Seattle, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Herz- und Diabeteszentrum NRW, Bad Oeynhausen
Bad Oeynhausen, , Germany
Herzzentrum Universitätsklinik Bonn
Bonn, , Germany
Herzzentrum der Uniklinik Köln
Cologne, , Germany
Herzzentrum Dresden Universitätsklinik
Dresden, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Klinikum der Universität München - Großhadern
München, , Germany
Countries
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References
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Arnold SV, Hahn RT, Thourani VH, Makkar R, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran N, Garcia S, Stewart-Dehner T, Grayburn PA, Sannino A, Snyder C, Zhang Y, Mack MJ, Leon MB, Lurz P, Kodali S, Cohen DJ; TRISCEND II Pivotal Trial Investigators. Quality of Life After Transcatheter Tricuspid Valve Replacement: 1-Year Results From TRISCEND II Pivotal Trial. J Am Coll Cardiol. 2025 Jan 28;85(3):206-216. doi: 10.1016/j.jacc.2024.10.067. Epub 2024 Oct 30.
Hahn RT, Makkar R, Thourani VH, Makar M, Sharma RP, Haeffele C, Davidson CJ, Narang A, O'Neill B, Lee J, Yadav P, Zahr F, Chadderdon S, Eleid M, Pislaru S, Smith R, Szerlip M, Whisenant B, Sekaran NK, Garcia S, Stewart-Dehner T, Thiele H, Kipperman R, Koulogiannis K, Lim DS, Fowler D, Kapadia S, Harb SC, Grayburn PA, Sannino A, Mack MJ, Leon MB, Lurz P, Kodali SK; TRISCEND II Trial Investigators. Transcatheter Valve Replacement in Severe Tricuspid Regurgitation. N Engl J Med. 2025 Jan 9;392(2):115-126. doi: 10.1056/NEJMoa2401918. Epub 2024 Oct 30.
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.
Lurz P, Kresoja KP. Tricuspid Valve Therapies: Closing the Gap. JACC Cardiovasc Interv. 2021 Jun 14;14(11):1241-1242. doi: 10.1016/j.jcin.2021.04.008. No abstract available.
Other Identifiers
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2020-05
Identifier Type: -
Identifier Source: org_study_id
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