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New treatment option for Severe or Greater Tricuspid Regurgitation
Official title A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.
ClinicalTrials.gov ID: NCT07433504
What this study is testing
What is Guideline Directed Medical Therapy?
Guideline Directed Medical Therapy is an investigational medicine, being studied as a potential treatment for severe or greater tricuspid regurgitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The transcatheter tricuspid valve clipping system is specially designed for the treatment of tricuspid regurgitation. Under the guidance of ultrasound and DSA imaging, the investigational device is advanced into the right ventricle via a femoral or jugular venous puncture approach.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years, male or female;
- Patients with severe or greater tricuspid regurgitation (TR ≥ 4+) judged by the local study team to have received adequate treatment according to...
- The multidisciplinary heart team (comprising cardiologists, cardiovascular surgeons, imaging specialists, anesthesiologists, etc., with at least 2...
- Left ventricular ejection fraction (LVEF) ≥ 20%;
- Presence of symptoms attributable to tricuspid regurgitation (e.g., chest distress, dyspnea, shortness of breath, lower extremity edema, ascites), or...
You likely can't join if
- Patients with pulmonary artery systolic pressure ≥ 60 mmHg: if right heart catheterization was performed, results shall be based on right heart...
- Tricuspid valve anatomy that, in the judgment of the core laboratory, may preclude implantation, proper positioning of the tricuspid clip device...
- Presence of a prosthetic valve or annuloplasty ring at the tricuspid valve position, or prior tricuspid valve surgery that, in the judgment of the...
- Tricuspid stenosis, defined as tricuspid valve area ≤ 1.0 cm² and/or mean tricuspid gradient \> 5 mmHg (assessed by the core laboratory).
- Tricuspid valve anatomy that cannot be evaluated by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
- Evidence of mass, thrombus, or vegetation in the cardiac chambers, access-related veins (jugular or femoral vein, depending on the selected access...
See the full eligibility criteria
Who can join
- Age ≥ 18 years, male or female;
- Patients with severe or greater tricuspid regurgitation (TR ≥ 4+) judged by the local study team to have received adequate treatment according to applicable standards and remained stable for at least 30 days (TR grading...
- The multidisciplinary heart team (comprising cardiologists, cardiovascular surgeons, imaging specialists, anesthesiologists, etc., with at least 2 physicians) judges that the subject is at moderate or high surgical risk...
- Left ventricular ejection fraction (LVEF) ≥ 20%;
- Presence of symptoms attributable to tricuspid regurgitation (e.g., chest distress, dyspnea, shortness of breath, lower extremity edema, ascites), or asymptomatic people with right ventricular dilation or impaired right...
- Impaired right ventricular function is defined as: tricuspid annular plane systolic excursion (TAPSE) \< 17 mm or fractional area change (FAC) \< 35%. NYHA functional class II to IV, inclusive;
- Subject voluntarily agrees to participate in the clinical trial and provides written informed consent, or consent is provided by the subject's legal representative.
What rules you out
- Patients with pulmonary artery systolic pressure ≥ 60 mmHg: if right heart catheterization was performed, results shall be based on right heart catheterization; if not performed, results shall be based on...
- Tricuspid valve anatomy that, in the judgment of the core laboratory, may preclude implantation, proper positioning of the tricuspid clip device, fail to sufficiently reduce TR severity, or achieve adequate leaflet...
- Presence of a prosthetic valve or annuloplasty ring at the tricuspid valve position, or prior tricuspid valve surgery that, in the judgment of the core laboratory, would interfere with study device implantation or...
- Tricuspid stenosis, defined as tricuspid valve area ≤ 1.0 cm² and/or mean tricuspid gradient \> 5 mmHg (assessed by the core laboratory).
- Tricuspid valve anatomy that cannot be evaluated by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
- Evidence of mass, thrombus, or vegetation in the cardiac chambers, access-related veins (jugular or femoral vein, depending on the selected access route for the individual subject), superior vena cava, or inferior vena...
- Patients in whom bilateral femoral veins are unsuitable for 23 Fr sheath access due to disease or anatomy, and bilateral jugular veins are unsuitable for 21 Fr sheath access (i.e., both transfemoral and transjugular...
- Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg).
- Prior implantation of a pacemaker (excluding leadless pacemakers) or implantable cardioverter-defibrillator (ICD), or planned implantation of a pacemaker (excluding leadless pacemakers) or ICD that, in the judgment of...
- Hemodynamic instability, defined as systolic blood pressure \< 90 mmHg, cardiogenic shock, requirement for inotropic support, intra-aortic balloon pump, or other hemodynamic support devices.
- End-stage refractory heart failure requiring specialized interventions (e.g., mechanical circulatory support, heart transplantation, etc.).
- Patients with more than moderate aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation; or patients scheduled for cardiac surgery within the next 12 months.
- Percutaneous coronary intervention within the previous 1 month.
- Myocardial infarction within the previous 1 month or known unstable angina.
- Cerebrovascular accident within the previous 3 months.
- Patients with active infective endocarditis or active rheumatic heart disease.
- Patients with coagulopathy, hypercoagulable state, or anemia (hemoglobin \< 90 g/L).
- Patients with acute infection or other severe infection.
- Patients with active peptic ulcer or active gastrointestinal bleeding.
- Transient ischemic attack (TIA) within 30 days, or prior stroke with permanent disability (mRS \> 4).
- Severe end-stage disease (e.g., malignant tumor, severe pulmonary disease, hepatic disease, renal failure) with life expectancy \< 1 year.
- Patients with known hypersensitivity or contraindications to the study device materials or study medications (e.g., antiplatelet agents, anticoagulants).
- Alcohol, drug, or substance addiction.
- Patients with cognitive impairment.
- History of primary or persistent epilepsy poorly controlled by medication, or psychiatric disorders.
- Participation in any other clinical trial (except registry studies) within 30 days prior to signing the informed consent form.
- Chronic dialysis patients.
- Females who are pregnant, breastfeeding, or planning to become pregnant during the clinical trial.
- Any other conditions deemed inappropriate by the investigator for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.