TRISCEND II Pivotal Trial

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Heart Failure; Heart Valve Diseases; Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease
• Intervention / Treatment: Device: Edwards EVOQUE System; Drug: Optimal Medical Therapy

Detailed Description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

• Study Type: Interventional
• Enrollment (Actual): 864
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum NRW, Bad Oeynhausen
  • Bonn, Germany, 53105
    • Herzzentrum Universitätsklinik Bonn
  • Cologne, Germany, 50937
    • Herzzentrum der Uniklinik Köln
  • Dresden, Germany, 01307
    • Herzzentrum Dresden Universitätsklinik
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Mainz, Germany, 55131
    • Johannes Gutenberg-Universität Mainz
  • München, Germany, 81377
    • Klinikum der Universitat Munchen - Grosshadern
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • SJHMC Heart and Vascular Institute
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital La Jolla
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • San Francisco, California, United States, 94118
      • Kaiser Permanente San Francisco
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies
  • Florida
    • Atlantis, Florida, United States, 33462
      • Florida Heart & Vascular Care - JFK
    • Gainesville, Florida, United States, 32605
      • The Cardiac & Vascular Institute Research Foundation
    • Naples, Florida, United States, 34102
      • NCH Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi St. Francis
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital and Health Systems
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
    • New Brunswick, New Jersey, United States, 08903
      • Rutgers Robert Wood Johnson Medical School
  • New York
    • Buffalo, New York, United States, 14203
      • State University of New York at Buffalo
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
    • New York, New York, United States, 10021
      • Weill Cornell Medicine-New York Presbyterian Hospital
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina - Chapel Hill
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Oklahoma Heart Institute
  • Oregon
    • Portland, Oregon, United States, 97293
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Heart Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Health
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77004
      • HCA Houston Healthcare
    • Plano, Texas, United States, 75093
      • Baylor Heart Hopsital Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Seattle, Washington, United States, 98101
      • Virginia Mason Franciscan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years old
• 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:

• Anatomy precluding proper device delivery, deployment and/or function
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Names: Transcatheter tricuspid valve replacement
Active Comparator: Optimal Medical Therapy (OMT); Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation	Drug: Optimal Medical Therapy; Optimal Medical Therapy
Experimental: 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	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Names: Transcatheter tricuspid valve replacement
Experimental: 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.	Device: Edwards EVOQUE System; Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT; Other Names: Transcatheter tricuspid valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction	Comparison of number of participants with reduction in TR between experimental and active comparator arms. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	6 months
Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement	Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms	6 months
Randomized Cohort: Rate of Major Adverse Events (MAE)	Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System & OMT)	30 days
Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6MWD improvement	Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms	1 year
Continued Access Study: Rate of Major Adverse Events (MAE)	Rate of MAEs in the Continued Access Study arm	30 days
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace	TR grade reduction to moderate, mild, or none/trace from baseline. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential); Lower grades of TR are better.	6 months
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.	6 months
Continued Access Study: New York Heart Association (NYHA) functional class	NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).	6 months
Continued Access Study: 6MWD	6MWD improvement of at least 30 meters	6 months
Continued Access Study: All-cause mortality	Deaths from any cause	1 year
Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant	Durable RVAD implantation or heart transplant	1 year
Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention	Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.	1 year
Continued Access Study: Annualized rate of heart failure hospitalizations	Annualized rate of heart failure hospitalizations	1 year
Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)	Improvement in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.	1 year
Continued Access Study: New York Heart Association (NYHA) functional class	NYHA functional class improvement of at least 1 class. NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).	1 year
Continued Access Study: 6MWD	6MWD improvement of at least 30 meters	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Randomized cohort: Tricuspid Regurgitation (TR) grade reduction	TR grade reduction from baseline to discharge (assessed up to 7 days post procedure). TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	Time Frame: Discharge (assessed up to 7 days post procedure)
Randomized cohort: All-Cause Mortality	Total number of deaths from any cause	1 year, annually through 5 years
Randomized cohort: Heart failure hospitalizations	Total number of patients with at least one hospital admission due to heart failure	1 year, annually through 5 years
Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)	Total number of patients with at least one non-elective tricuspid valve re-intervention	1 year, annually through 5 years
Randomized cohort: Durable RVAD implantation or heart transplant	Total number of patients requiring RVAD implantation or heart transplant	1 year, annually through 5 years
Randomized cohort: Need for paracentesis	Total number of patients who required paracentesis	1 year, annually through 5 years
Randomized cohort: Reduction in TR grade by at least one grade	Total number of patients with at least one grade TR reduction	1 year
Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade	Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).	1 year
Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline	Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.	1 year
Randomized cohort: Death and heart failure hospitalization	Comparison of number of wins with death and HFH between experimental and active comparator arms	1 year
Randomized cohort: All-cause hospitalizations	Total number of patients with hospitalizations from any cause	1 year
Randomized cohort: All-cause mortality	Total number of patients with deaths from any cause	1 year
Randomized cohort: Change in 6MWD from baseline	Change in 6MWD from baseline	1 year
Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction	TR grade reduction from baseline to discharge (assessed up to 7 days post procedure). TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	Time Frame: Discharge (assessed up to 7 days post procedure)
Roll-in cohort: All-cause mortality	Total number of deaths from any cause	1 year, annually through 5 years
Roll-in cohort: Heart failure hospitalizations	Total number of hospital admissions due to heart failure	1 year, annually through 5 years
Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)	Total number of non-elective tricuspid valve re-interventions	1 year, annually through 5 years
Roll-in cohort: Durable RVAD implantation or heart transplant	Total number of patients requiring RVAD implantation or heart transplant	1 year, annually through 5 years
Roll-in cohort: Need for paracentesis	Total number of patients who required paracentesis	1 year, annually through 5 years
Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade	Total number of patients with at least one grade TR reduction. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	1 year
Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade	Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).	1 year
Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline	Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.	1 year
Roll-in cohort: Death and heart failure hospitalization	Total number of patients with death or heart failure hospitalization	1 year
Roll-in cohort: All-cause hospitalizations	Total number of patients with hospitalizations from any cause	1 year
Roll-in cohort: All-cause mortality	Total number of patients with deaths from any cause	1 year
Roll-in cohort: Change in 6MWD from baseline	Change in 6MWD from baseline	1 year
Registry cohort: Tricuspid Regurgitation (TR) grade reduction	TR grade reduction from baseline to discharge. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	Time Frame: Discharge (assessed up to 7 days post procedure)
Registry cohort: All-cause mortality	Total number of deaths from any cause	1 year, annually through 5 years
Registry cohort: Heart failure hospitalizations	Total number of hospital admissions due to heart failure	1 year, annually through 5 years
Registry cohort: Change in 6MWD from baseline	Change in 6MWD from baseline	1 year
Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)	Total number of non-elective tricuspid valve re-interventions	1 year, annually through 5 years
Registry cohort: Durable RVAD implantation or heart transplant	Total number of patients requiring RVAD implantation or heart transplant	1 year, annually through 5 years
Registry cohort: Need for paracentesis	Total number of patients who required paracentesis	1 year, annually through 5 years
Registry cohort: Reduction in TR grade by at least one grade	Total number of patients with at least one grade TR reduction	1 year
Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade	Total number of patients with NYHA functional class improvement of at least 1 class. The NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).	1 year
Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline	Change in QOL (by KCCQ overall summary score) of at least 10 points. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better QOL.	1 year
Registry cohort: Death and heart failure hospitalization	Total number of patients with death and heart failure hospitalization	1 year
Registry cohort: All-cause hospitalizations	Total number of patients with hospitalizations from any cause	1 year
Registry cohort: All-cause mortality	Total number of patients with deaths from any cause	1 year
Continued Access Study: Tricuspid Regurgitation (TR) grade reduction	TR grade reduction from baseline to discharge. TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.	Time Frame: Discharge (assessed up to 7 days post procedure)
Continued Access Study: All-cause mortality	Total number of deaths from any cause	1 year, annually through 5 years
Continued Access Study: Heart failure hospitalizations	Total number of hospital admissions due to heart failure	1 year, annually through 5 years
Continued Access Study: Non-elective tricuspid valve re-intervention (percutaneous or surgical)	Total number of non-elective tricuspid valve re-interventions	1 year, annually through 5 years
Continued Access Study: Durable RVAD implantation or heart transplant	Total number of patients requiring RVAD implantation or heart transplant	1 year, annually through 5 years
Continued Access Study: Need for paracentesis	Total number of patients who required paracentesis	1 year, annually through 5 years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Rebecca Hahn, MD, Columbia University; Principal Investigator: Philipp Lurz, MD, Herzzentrum Leipzig GmbH; Principal Investigator: Vinod Thourani, MD, Piedmont Heart Institute; Principal Investigator: Susheel Kodali, MD, Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2021
• Primary Completion (Actual): December 5, 2025
• Study Completion (Estimated): June 27, 2030

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Heart Failure; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2020-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes