A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement

Jiangsu Trulive Medical Co., Ltd180 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease

Interventions

TruGamma SystemDEVICE

Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with OMT

Optimal medical therapy (OMT)DRUG

Optimal Medical Therapy

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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 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).

Time frame: 12months

Tricuspid Regurgitation (TR) severity

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.

Time frame: 12months

Rate of Major Adverse Events (MAE)

Rate of Major Adverse Events (MAE) in experimental arm（TruGamma System in conjunction with OMT）

Time frame: 30 days

Secondary Outcomes

Procedural success rate

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.

Central Contacts

Yuxiao Guo

CONTACT

+86 18221025921 kate.g@trulive.cn

Data from ClinicalTrials.gov

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