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Active, Not Recruiting

NCT Number: NCT04482062

TRISCEND II Pivotal Trial

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Failure Heart Valve Diseases Tricuspid Valve Disease Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Bad Oeynhausen, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • PASP >60 mmHg by echo Doppler (unless RHC demonstrates PASP ≤70 mmHg)
  • PASP >70 mmHg by RHC
  • 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:
  • Implanted in the RV within the last90 days
  • Patient is pacemaker dependent5 on trans-tricuspid lead without alternative pacing option
  • 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:
  • Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days
  • Carotid surgery within the last 30 days
  • Direct current cardioversion within the last 30 days
  • Leadless RV pacemaker implant within the last 30 days
  • 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):
  • TEE is contraindicated or cannot be completed
  • 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

Treatment and study plan

Edwards EVOQUE System

Device

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT

Other names: Transcatheter tricuspid valve replacement

Optimal medical therapy

Drug

Optimal Medical Therapy

Primary outcomes

  1. Randomized Cohort: Tricuspid Regurgitation (TR) grade reduction

    Time frame: 6 months

    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.

  2. 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

    Time frame: 6 months

    Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arms

  3. Randomized Cohort: Rate of Major Adverse Events (MAE)

    Time frame: 30 days

    Rate of Major Adverse Events (MAE) in experimental arm (Edwards EVOQUE System & OMT)

  4. 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

    Time frame: 1 year

    Comparison of number of wins with composite endpoint events or improvement between experimental and active comparator arms

  5. Continued Access Study: Rate of Major Adverse Events (MAE)

    Time frame: 30 days

    Rate of MAEs in the Continued Access Study arm

  6. Continued Access Study: Tricuspid Regurgitation (TR) grade reduction to moderate, mild, or none/trace

    Time frame: 6 months

    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.

  7. Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 6 months

    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.

  8. Continued Access Study: New York Heart Association (NYHA) functional class

    Time frame: 6 months

    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).

  9. Continued Access Study: 6MWD

    Time frame: 6 months

    6MWD improvement of at least 30 meters

  10. Continued Access Study: All-cause mortality

    Time frame: 1 year

    Deaths from any cause

  11. Continued Access Study: Durable right ventricular assist device (RVAD) implantation or heart transplant

    Time frame: 1 year

    Durable RVAD implantation or heart transplant

  12. Continued Access Study: Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention

    Time frame: 1 year

    Total number of patients requiring tricuspid valve surgery or percutaneous tricuspid intervention.

  13. Continued Access Study: Annualized rate of heart failure hospitalizations

    Time frame: 1 year

    Annualized rate of heart failure hospitalizations

  14. Continued Access Study: Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 1 year

    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.

  15. Continued Access Study: New York Heart Association (NYHA) functional class

    Time frame: 1 year

    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).

  16. Continued Access Study: 6MWD

    Time frame: 1 year

    6MWD improvement of at least 30 meters

Secondary outcomes

  1. Randomized cohort: Tricuspid Regurgitation (TR) grade reduction

    Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)

    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.

  2. Randomized cohort: All-Cause Mortality

    Time frame: 1 year, annually through 5 years

    Total number of deaths from any cause

  3. Randomized cohort: Heart failure hospitalizations

    Time frame: 1 year, annually through 5 years

    Total number of patients with at least one hospital admission due to heart failure

  4. Randomized cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)

    Time frame: 1 year, annually through 5 years

    Total number of patients with at least one non-elective tricuspid valve re-intervention

  5. Randomized cohort: Durable RVAD implantation or heart transplant

    Time frame: 1 year, annually through 5 years

    Total number of patients requiring RVAD implantation or heart transplant

  6. Randomized cohort: Need for paracentesis

    Time frame: 1 year, annually through 5 years

    Total number of patients who required paracentesis

  7. Randomized cohort: Reduction in TR grade by at least one grade

    Time frame: 1 year

    Total number of patients with at least one grade TR reduction

  8. Randomized cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade

    Time frame: 1 year

    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).

  9. Randomized cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline

    Time frame: 1 year

    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.

  10. Randomized cohort: Death and heart failure hospitalization

    Time frame: 1 year

    Comparison of number of wins with death and HFH between experimental and active comparator arms

  11. Randomized cohort: All-cause hospitalizations

    Time frame: 1 year

    Total number of patients with hospitalizations from any cause

  12. Randomized cohort: All-cause mortality

    Time frame: 1 year

    Total number of patients with deaths from any cause

  13. Randomized cohort: Change in 6MWD from baseline

    Time frame: 1 year

    Change in 6MWD from baseline

  14. Roll-in cohort: Tricuspid Regurgitation (TR) grade reduction

    Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)

    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.

  15. Roll-in cohort: All-cause mortality

    Time frame: 1 year, annually through 5 years

    Total number of deaths from any cause

  16. Roll-in cohort: Heart failure hospitalizations

    Time frame: 1 year, annually through 5 years

    Total number of hospital admissions due to heart failure

  17. Roll-in cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)

    Time frame: 1 year, annually through 5 years

    Total number of non-elective tricuspid valve re-interventions

  18. Roll-in cohort: Durable RVAD implantation or heart transplant

    Time frame: 1 year, annually through 5 years

    Total number of patients requiring RVAD implantation or heart transplant

  19. Roll-in cohort: Need for paracentesis

    Time frame: 1 year, annually through 5 years

    Total number of patients who required paracentesis

  20. Roll-in cohort: Reduction in tricuspid regurgitation (TR) grade by at least one grade

    Time frame: 1 year

    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.

  21. Roll-in cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade

    Time frame: 1 year

    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).

  22. Roll-in cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline

    Time frame: 1 year

    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.

  23. Roll-in cohort: Death and heart failure hospitalization

    Time frame: 1 year

    Total number of patients with death or heart failure hospitalization

  24. Roll-in cohort: All-cause hospitalizations

    Time frame: 1 year

    Total number of patients with hospitalizations from any cause

  25. Roll-in cohort: All-cause mortality

    Time frame: 1 year

    Total number of patients with deaths from any cause

  26. Roll-in cohort: Change in 6MWD from baseline

    Time frame: 1 year

    Change in 6MWD from baseline

  27. Registry cohort: Tricuspid Regurgitation (TR) grade reduction

    Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)

    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.

  28. Registry cohort: All-cause mortality

    Time frame: 1 year, annually through 5 years

    Total number of deaths from any cause

  29. Registry cohort: Heart failure hospitalizations

    Time frame: 1 year, annually through 5 years

    Total number of hospital admissions due to heart failure

  30. Registry cohort: Change in 6MWD from baseline

    Time frame: 1 year

    Change in 6MWD from baseline

  31. Registry cohort: Non-elective tricuspid valve re-intervention (percutaneous or surgical)

    Time frame: 1 year, annually through 5 years

    Total number of non-elective tricuspid valve re-interventions

  32. Registry cohort: Durable RVAD implantation or heart transplant

    Time frame: 1 year, annually through 5 years

    Total number of patients requiring RVAD implantation or heart transplant

  33. Registry cohort: Need for paracentesis

    Time frame: 1 year, annually through 5 years

    Total number of patients who required paracentesis

  34. Registry cohort: Reduction in TR grade by at least one grade

    Time frame: 1 year

    Total number of patients with at least one grade TR reduction

  35. Registry cohort: Reduction in New York Heart Association (NYHA) functional class by at least one grade

    Time frame: 1 year

    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).

  36. Registry cohort: Change in Quality of Life (QOL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline

    Time frame: 1 year

    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.

  37. Registry cohort: Death and heart failure hospitalization

    Time frame: 1 year

    Total number of patients with death and heart failure hospitalization

  38. Registry cohort: All-cause hospitalizations

    Time frame: 1 year

    Total number of patients with hospitalizations from any cause

  39. Registry cohort: All-cause mortality

    Time frame: 1 year

    Total number of patients with deaths from any cause

  40. Continued Access Study: Tricuspid Regurgitation (TR) grade reduction

    Time frame: Time Frame: Discharge (assessed up to 7 days post procedure)

    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.

  41. Continued Access Study: All-cause mortality

    Time frame: 1 year, annually through 5 years

    Total number of deaths from any cause

  42. Continued Access Study: Heart failure hospitalizations

    Time frame: 1 year, annually through 5 years

    Total number of hospital admissions due to heart failure

  43. Continued Access Study: Non-elective tricuspid valve re-intervention (percutaneous or surgical)

    Time frame: 1 year, annually through 5 years

    Total number of non-elective tricuspid valve re-interventions

  44. Continued Access Study: Durable RVAD implantation or heart transplant

    Time frame: 1 year, annually through 5 years

    Total number of patients requiring RVAD implantation or heart transplant

  45. Continued Access Study: Need for paracentesis

    Time frame: 1 year, annually through 5 years

    Total number of patients who required paracentesis

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2030
First posted
Jul 22, 2020
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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