A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve… (NCT07433504) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.
China132 participantsStarted 2026-01-28
Plain-language summary
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. The clipping component grasps the edges of the dysfunctional valve leaflets (usually unable to close properly), thereby reducing the area of the tricuspid orifice that fails to coapt normally, achieving minimally invasive treatment of tricuspid regurgitation.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 to be determined by the core laboratory);
. 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 (Tri-Score ≥ 4.0) and is expected to benefit from tricuspid edge-to-edge repair;
. 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 subjects with right ventricular dilation or impaired right ventricular function (as determined by the core laboratory);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of subjects free of all-cause death or tricuspid valve reoperation, free of heart failure readmission, and with ≥15-point improvement in the Kansas City Cardiomyopathy Questionnaire score at 1 year after treatment.
. Impaired right ventricular function is defined as: tricuspid annular plane systolic excursion (TAPSE) \< 17 mm or fractional area change (FAC) \< 35%.
. Subject voluntarily agrees to participate in the clinical trial and provides written informed consent, or consent is provided by the subject's legal representative.
Exclusion criteria
. 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 echocardiography (assessed by the core laboratory).
. 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 apposition, including but not limited to:
. 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 therapeutic effect.
. 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 cava (depending on the selected access route for the individual subject).
. 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 access are contraindicated).