Tricuspid Valve Disease, Tricuspid Valve Insufficiency, Tricuspid Valve Regurgitation
Conditions
Keywords
tricuspid valve replacement
Brief summary
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
Detailed description
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the TruGamma 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.
Interventions
DEVICETruGamma System
Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with OMT
Optimal Medical Therapy
Sponsors
Jiangsu Trulive Medical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥65 years old. 2. The subject must be assessed by the local heart team as a high-risk patient ineligible for surgery and has been stabilized on optimal medical therapy (OMT)（The OMT is evaluated by the local heart team and comprises medications including diuretics with a treatment duration of no less than 30 days; no medication was newly initiated or discontinued within the preceding 2 weeks before treatment, any dose reduction did not exceed 50% of the original dose, and any dose escalation did not exceed 100% of the original dose.）. 3. Despite OMT per the local heart team, patient has signs of TR or symptoms fromTR，and TR graded as at least severe on a TTE(assessedby the 5-grade classification). 4. New York Heart Association (NYHA) Class III-IV. 5. The local heart team determines that the subject's anatomy is appropriate for transcatheter tricuspid valve replacement. 6. Subject is willing and able to comply with all study evaluations and provideswritten informed consent.
Exclusion criteria
1. Transesophageal echocardiography (TEE) is contraindicated or cannot be completed. 2. Pulmonary arterial systolic pressure (PASP) \>60 mmHg by Dopplerechocardiogram (unless right heart catheterization \[RHC\] demonstrates PASP ≤60 mmHg). 3. Left ventricular ejection fraction (LVEF) ≤ 25%. 4. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation requiring surgical intervention. 5. Previous tricuspid surgery or intervention. 6. Patients with congenital Ebstein's anomaly or hypoplastic right ventricle. 7. Patients with right ventricular outflow tract obstruction,or hemodynamically significant pericardial effusion,or significant intracardiac mass, thrombus, or vegetation. 8. Active endocarditis within the last 90 days or infection requiring antibiotictherapy within the last 14 days. 9. Hemodynamic instability with cardiogenic shock or severe hemodynamic compromise, defined as systolic blood pressure (SBP) \<90 mmHg with or without vasoactive or afterload-reducing agents, cardiogenic shock , or the need for an intra-aortic balloon pump (IABP), or other mechanical circulatory support (MCS) devices. 10. Patients with respiratory failure who are deemed to be unsuitable candidates for general anesthesia. 11. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \<30mL/min/1.73m2,or requiring chronic renal replacement therapy. 12. Patients with hepatic insufficiency, or cirrhosis with Meld-3.0 score \>17. 13. Clinically significant, untreated coronary artery disease requiringrevascularization, recent acute coronary syndrome within the last 30 days. 14. Any major cardiac, coronary, or cervical vascular surgery within the last 30 days. 15. Pacemaker or ICD leads that may interfere with implantation of the tricuspid valve system. 16. Pulmonary embolism in the last 6 months (180 days). 17. Ischemic or hemorrhagic stroke within the last 90 days . 18. Active peptic ulcer disease or upper gastrointestinal bleeding within the last 90 days. 19. Chronic anemia with transfusion dependency or Hgb\<90g/L not corrected by transfusion. 20. Thrombocytopenia (platelet count\<75,000/mm3) or thrombocytosis (plateletcount \>750,000/mm2). 21. Unable to perform the 6-minute walk test (6MWT). 22. Hypersensitivity reaction or known allergy to the raw materials of the investigational device ,or other allergy cannot be adequately managed with medication. 23. Severe Alzheimer's disease. 24. Known contraindication, allergy, or hypersensitivity to BOTH dual antiplatelet therapy AND anticoagulant therapy. A contraindication to either DAPT or anticoagulant therapy alone does not constitute an exclusion criterion. 25. Active malignancy or life expectancy ≤1 year, in the opinion of the investigator. 26. Severe uncontrolled hypertension. 27. Pregnancy, breastfeeding, or a positive pregnancy test at screening, or intention to become pregnant during the study period. (Women with documented history of menopause are exempt.) 28. Concurrent participation in another investigational drug or device clinical trial in which the primary endpoint has not yet been reached. 29. In the opinion of the investigator, the subject is unlikely to comply with study procedures or to complete the study as required. 30. Any other condition or circumstance that, in the judgment of the investigator, would make the subject inappropriate for study enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12months | Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arm.KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better health status.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). |
| Tricuspid Regurgitation (TR) severity | 12months | Comparison of percentage of patients with tricuspid regurgitation of 2+ or less between experimental and active comparator arm.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. |
| Rate of Major Adverse Events (MAE) | 30 days | Rate of Major Adverse Events (MAE) in experimental arm（TruGamma System in conjunction with OMT） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success rate | Immediately after procedure | Procedural success rate in experimental arm.Criteria for procedural success (all of the following items shall be satisfied): No intraprocedural death or stroke;The device is successfully delivered via the jugular vein into the right atrium, across the tricuspid valve and into the right ventricle, followed by deployment of the prosthetic valve and removal of the delivery system;The implanted valve is positioned at an appropriate anatomical site;No moderate or greater transvalvular regurgitation, no moderate or greater paravalvular leakage, and no tricuspid stenosis of the implanted valve;No device-related forward flow obstruction or pulmonary embolism; No device- or access site-related complications requiring urgent reoperation or other reintervention within 24 hours after the procedure. |
| Clinical success rate | 30 days | Clinical success rate in experimental arm.Criteria for clinical success (all of the following shall be met): No procedural death or stroke; The implanted valve is positioned at an appropriate anatomical site, with no moderate or greater transvalvular regurgitation, no moderate or greater paravalvular leakage and no tricuspid stenosis. There are no device- or access site-related complications requiring reoperation or other reintervention; No major adverse events (MAE) related to the device or procedure. |
| System performance evaluation | Immediately after procedure | Intraoperative performance evaluation of the transcatheter tricuspid valve system, including overall device performance, ease of use of the delivery system, compatibility of the delivery system with the loaded prosthetic valve, priming performance, visualization, pushability and trackability of the delivery system, compatibility among all components of the delivery system, hemostatic performance of the delivery system, positioning function for the prosthetic valve, leaflet capture and control function, interaction between the system and adjacent anatomical structures, stability and operability during valve deployment, and retraction performance. Thrombosis or embolism shall also be assessed.The evaluation is graded into four levels: Excellent, Good, Fair, Poor. |
| Tricuspid Regurgitation (TR) grade reduction | 30 days, 6 months, 12 months | Comparison of number of participants with reduction in TR between between experimental and active comparator arm.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. |
| Change in KCCQ from baseline | 30 days, 6 months, 12 months | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline.KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better health status. |
| Reduction in New York Heart Association (NYHA) functional class | 30 days, 6 months, 12 months | Total number of patients with 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). |
| Change in 6MWD from baseline | 30 days, 6 months, 12 months | Change in 6MWD from baseline |
| Change in Quality of Life (QOL) | 30 days, 6 months, 12 months | Comparison of percentage of patients with improvement in any one of the three indicators - KCCQ score, NYHA functional class, or 6-minute walk test distance between experimental and active comparator arm. KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better health status.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). |
| Heart failure hospitalizations | 30 days, 6 months, 12 months | Total number of patients with at least one hospital admission due to heart failure |
| Edema grade | 30 days, 6 months, 12 months | 4-level assessment of edema severity |
| All-Cause Mortality | 30 days, 6 months, 12 months | Total number of deaths from any cause |
| Tricuspid valve re-intervention (percutaneous or surgical) | 30 days, 6 months, 12 months | Total number of patients with at least one non-elective tricuspid valve re-intervention |
| Rate of Major Adverse Events (MAE) | 6 months, 12 months | Rate of Major Adverse Events (MAE) in treatment arm（TruGamma System in conjunction with OMT） |
Countries
China
Contacts
CONTACTYuxiao Guo
Outcome results
None listed