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Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edwards EVOQUE System & OMT | Experimental | 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) | Active Comparator | Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation |
|
| Single-Arm Registry | Experimental | 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 |
|
| Continued Access Study | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards EVOQUE System | Device | Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT |
|
| 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 |
| 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) |
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Inclusion Criteria:
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:
Previous tricuspid surgery or intervention
Presence of trans-tricuspid pacemaker or defibrillator lead with any of the following:
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:
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):
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
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Hahn, MD | Columbia University | Principal Investigator |
| Susheel Kodali, MD | Columbia University | Principal Investigator |
| Philipp Lurz, MD | Herzzentrum Leipzig GmbH | Principal Investigator |
| Vinod Thourani, MD | Piedmont Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SJHMC Heart and Vascular Institute | Phoenix | Arizona | 85013 | United States | ||
| Tucson Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39480380 | Derived | 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. | |
| 39475399 |
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|
| Optimal Medical Therapy | Drug | Optimal Medical Therapy |
|
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 |
| 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 |
| Tucson |
| Arizona |
| 85712 |
| United States |
| Scripps Memorial Hospital La Jolla | La Jolla | California | 92037 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
| Kaiser Permanente San Francisco | San Francisco | California | 94118 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | United States |
| Florida Heart & Vascular Care - JFK | Atlantis | Florida | 33462 | United States |
| The Cardiac & Vascular Institute Research Foundation | Gainesville | Florida | 32605 | United States |
| NCH Heart Institute | Naples | Florida | 34102 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30309 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | United States |
| Ascension Via Christi St. Francis | Wichita | Kansas | 67214 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Hospital and Health Systems | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
| State University of New York at Buffalo | Buffalo | New York | 14203 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oklahoma Heart Institute | Tulsa | Oklahoma | 74104 | United States |
| Oregon Health & Science University | Portland | Oregon | 97293 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Lankenau Heart Institute | Wynnewood | Pennsylvania | 19096 | United States |
| Saint Thomas Health | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| HCA Houston Healthcare | Houston | Texas | 77004 | United States |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Baylor Heart Hopsital Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Virginia Mason Franciscan Health | Seattle | Washington | 98101 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Herz- und Diabeteszentrum NRW, Bad Oeynhausen | Bad Oeynhausen | 32545 | Germany |
| Herzzentrum Universitätsklinik Bonn | Bonn | 53105 | Germany |
| Herzzentrum der Uniklinik Köln | Cologne | 50937 | Germany |
| Herzzentrum Dresden Universitätsklinik | Dresden | 01307 | Germany |
| Herzzentrum Leipzig GmbH | Leipzig | 04289 | Germany |
| Johannes Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Klinikum der Universität München - Großhadern | München | 81377 | Germany |
| Derived |
| 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. |
| 35272771 | Derived | 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. |
| 34112461 | Derived | 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. |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006349 | Heart Valve Diseases |
| D002318 | Cardiovascular Diseases |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
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