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

Recruiting now · Not applicable

Conditions studied: Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease

In brief

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

Key facts

Study ID

NCT07691307

Run by

Jiangsu Trulive Medical Co., Ltd

People needed

180

Starts

2026-03-18

Expected to finish

2028-08-30

Last updated by the study team

2026-07-08

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥65 years old.
• 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.）.
• 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).
• New York Heart Association (NYHA) Class III-IV.
• The local heart team determines that the subject's anatomy is appropriate for transcatheter tricuspid valve replacement.
• Subject is willing and able to comply with all study evaluations and provideswritten informed consent.

You may not qualify if…

• Transesophageal echocardiography (TEE) is contraindicated or cannot be completed.
• Pulmonary arterial systolic pressure (PASP) >60 mmHg by Dopplerechocardiogram (unless right heart catheterization [RHC] demonstrates PASP ≤60 mmHg).
• Left ventricular ejection fraction (LVEF) ≤ 25%.
• Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation requiring surgical intervention.
• Previous tricuspid surgery or intervention.
• Patients with congenital Ebstein's anomaly or hypoplastic right ventricle.
• Patients with right ventricular outflow tract obstruction,or hemodynamically significant pericardial effusion,or significant intracardiac mass, thrombus, or vegetation.
• Active endocarditis within the last 90 days or infection requiring antibiotictherapy within the last 14 days.
• 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.
• Patients with respiratory failure who are deemed to be unsuitable candidates for general anesthesia.
• Severe renal insufficiency with estimated glomerular filtration rate (eGFR) <30mL/min/1.73m2,or requiring chronic renal replacement therapy.
• Patients with hepatic insufficiency, or cirrhosis with Meld-3.0 score >17.
• Clinically significant, untreated coronary artery disease requiringrevascularization, recent acute coronary syndrome within the last 30 days.
• Any major cardiac, coronary, or cervical vascular surgery within the last 30 days.
• Pacemaker or ICD leads that may interfere with implantation of the tricuspid valve system.
• Pulmonary embolism in the last 6 months (180 days).
• Ischemic or hemorrhagic stroke within the last 90 days .
• Active peptic ulcer disease or upper gastrointestinal bleeding within the last 90 days.
• Chronic anemia with transfusion dependency or Hgb<90g/L not corrected by transfusion.
• Thrombocytopenia (platelet count<75,000/mm3) or thrombocytosis (plateletcount >750,000/mm2).
• Unable to perform the 6-minute walk test (6MWT).
• Hypersensitivity reaction or known allergy to the raw materials of the investigational device ,or other allergy cannot be adequately managed with medication.
• Severe Alzheimer's disease.
• 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.
• Active malignancy or life expectancy ≤1 year, in the opinion of the investigator.

Where it is running

• Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.