Tricuspid Valve RegurgitationNCT07691307
A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement
A study testing TruGamma System and Optimal medical therapy (OMT) in people with Tricuspid Valve Regurgitation and Tricuspid Valve Insufficiency, run by Jiangsu Trulive Medical Co., Ltd at 1 site in China.
Trial summary
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Tricuspid Valve Regurgitation, Tricuspid Valve Insufficiency, Tricuspid Valve Disease
- What is being tested?
- TruGamma System and Optimal medical therapy (OMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2026to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 30Show fewer
- 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.
- Severe uncontrolled hypertension.
- 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.)
- Concurrent participation in another investigational drug or device clinical trial in which the primary endpoint has not yet been reached.
- In the opinion of the investigator, the subject is unlikely to comply with study procedures or to complete the study as required.
- Any other condition or circumstance that, in the judgment of the investigator, would make the subject inappropriate for study enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Xiangbin Pan, +86 13811763898, xiangbin428@hotmail.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial Protocol Evaluating the Safety and Efficacy of the TruGamma Transcatheter Tricuspid Valve System in Patients With Severe Tricuspid Regurgitation
Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system
Read the 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.
- Being tested
- TruGamma System, Optimal medical therapy (OMT)
- Keywords
- tricuspid valve replacement
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruGamma SystemDevice
Also called Transcatheter tricuspid valve replacement
Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with OMT
Optimal medical therapy (OMT)Drug
Optimal Medical Therapy
| Study group | Role | What they receive |
|---|---|---|
| TruGamma System & OMT | Experimental | Transcatheter tricuspid valve replacement with the TruGamma System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation. Receives: Device: TruGamma System |
| Optimal Medical Therapy (OMT) | Active comparator | Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation Receives: Drug: Optimal medical therapy (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 12months
Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in experimental arm（TruGamma System in conjunction with OMT）
Measured: 30 days
Secondary outcomes (13)
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.
Measured: Immediately after procedure
Clinical success rate
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.
Measured: 30 days
System performance evaluation
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.
Measured: Immediately after procedure
Tricuspid Regurgitation (TR) grade reduction
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.
Measured: 30 days, 6 months, 12 months
Change in KCCQ from baseline
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.
Measured: 30 days, 6 months, 12 months
Reduction in New York Heart Association (NYHA) functional class
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).
Measured: 30 days, 6 months, 12 months
Change in 6MWD from baseline
Change in 6MWD from baseline
Measured: 30 days, 6 months, 12 months
Change in Quality of Life (QOL)
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).
Measured: 30 days, 6 months, 12 months
Heart failure hospitalizations
Total number of patients with at least one hospital admission due to heart failure
Measured: 30 days, 6 months, 12 months
Edema grade
4-level assessment of edema severity
Measured: 30 days, 6 months, 12 months
All-Cause Mortality
Total number of deaths from any cause
Measured: 30 days, 6 months, 12 months
Tricuspid valve re-intervention (percutaneous or surgical)
Total number of patients with at least one non-elective tricuspid valve re-intervention
Measured: 30 days, 6 months, 12 months
Rate of Major Adverse Events (MAE)
Rate of Major Adverse Events (MAE) in treatment arm（TruGamma System in conjunction with OMT）
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start18 Mar 2026
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Trulive Medical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691307
- Sponsor's protocol ID
- ZY04-CIP-03
- Status last verified
- Jul 2026
- First submitted
- 24 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial Protocol Evaluating the Safety and Efficacy of the TruGamma Transcatheter Tricuspid Valve System in Patients With Severe Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT07691307
- Acronym / sponsor ID
- ZY04-CIP-03
- Keywords
- tricuspid valve replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Jiangsu Trulive Medical Co., LtdUniversity, hospital or other
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TruGamma System & OMT | Experimental | Device: TruGamma SystemTranscatheter tricuspid valve replacement with the TruGamma System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation. |
| Optimal Medical Therapy (OMT) | Active comparator | Drug: Optimal medical therapy (OMT)Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (30 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruGamma SystemAlso: Transcatheter tricuspid valve replacementTranscatheter tricuspid valve replacement with the TruGamma System in conjunction with OMT | Device | TruGamma System & OMT |
| Optimal medical therapy (OMT)Optimal Medical Therapy | Drug | Optimal Medical Therapy (OMT) |
Primary outcome
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: 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
Time frame: 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)
Time frame: 30 days
Rate of Major Adverse Events (MAE) in experimental arm（TruGamma System in conjunction with OMT）
13 secondary outcomes
Procedural success rate
Time frame: Immediately after procedure
Clinical success rate
Time frame: 30 days
System performance evaluation
Time frame: Immediately after procedure
Tricuspid Regurgitation (TR) grade reduction
Time frame: 30 days, 6 months, 12 months
Change in KCCQ from baseline
Time frame: 30 days, 6 months, 12 months
Reduction in New York Heart Association (NYHA) functional class
Time frame: 30 days, 6 months, 12 months
Change in 6MWD from baseline
Time frame: 30 days, 6 months, 12 months
Change in Quality of Life (QOL)
Time frame: 30 days, 6 months, 12 months
Heart failure hospitalizations
Time frame: 30 days, 6 months, 12 months
Edema grade
Time frame: 30 days, 6 months, 12 months
All-Cause Mortality
Time frame: 30 days, 6 months, 12 months
Tricuspid valve re-intervention (percutaneous or surgical)
Time frame: 30 days, 6 months, 12 months
Rate of Major Adverse Events (MAE)
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TruGamma System and Optimal medical therapy (OMT) in people with Tricuspid Valve Regurgitation and Tricuspid Valve Insufficiency, run by Jiangsu Trulive Medical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuxiao Guo (+86 18221025921, kate.g@trulive.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 12months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.