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

NCT07691307 | Recruiting DMC

• 1 other identifier: ZY04-CIP-03
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease

Keywords

tricuspid valve replacement

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  12months

• Rate of Major Adverse Events (MAE)

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

  30 days

Secondary Outcomes (13)

• Procedural success rate

  Immediately after procedure

• Clinical success rate

  30 days

• System performance evaluation

  Immediately after procedure

• Tricuspid Regurgitation (TR) grade reduction

  30 days, 6 months, 12 months

• Change in KCCQ from baseline

  30 days, 6 months, 12 months

Study Arms (2)

TruGamma System & OMT

EXPERIMENTAL

Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Device: TruGamma System

Optimal Medical Therapy (OMT)

ACTIVE COMPARATOR

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Drug: Optimal medical therapy (OMT)

Interventions

TruGamma System DEVICE

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

Also known as: Transcatheter tricuspid valve replacement

TruGamma System & OMT

Optimal medical therapy (OMT) DRUG

Optimal Medical Therapy

Optimal Medical Therapy (OMT)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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.

Sponsors & Collaborators

• Jiangsu Trulive Medical Co., Ltd: lead

Study Sites (1)

Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Yuxiao Guo

CONTACT

+86 18221025921; kate.g@trulive.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 8, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)