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A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems. | Clinical Trials | Clareo Health

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A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

A Prospective, Multicenter, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Transcatheter Tricuspid Valve Clipping Systems in Patients With Severe or Greater Tricuspid Regurgitation.

NCT07433504•Shanghai Huihe Medical Technology Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 years, male or female;
•2. 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);
•Adequate treatment is defined as:
•Oral diuretic therapy for tricuspid regurgitation at a stable dose for at least 30 days; Guideline-directed medical therapy for heart failure (if applicable) according to heart failure subtype with different ejection fractions, at a stable dose for at least 30 days; For subjects with mitral regurgitation (MR ≥ 3+), atrial fibrillation, or coronary artery disease: medical therapy for ≥ 30 days, or ≥ 30 days post device-based therapy with stable clinical status.
•Stable dose is defined as: dose increase ≤ 100% or dose reduction ≤ 50%.
•3. 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;
•4. Left ventricular ejection fraction (LVEF) ≥ 20%;
•5. 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);
•6. 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;
+1 more criteria

Exclusion Criteria

•1. 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).
•2. 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:
•Severe calcification in the leaflet grasping zone; Severe leaflet perforation, cleft, or other lesions that impede device implantation; Ebstein's anomaly; TR expected to be unamenable to reduction to grade 2+ or lower post-procedure with edge-to-edge repair.
•3. 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.
•4. Tricuspid stenosis, defined as tricuspid valve area ≤ 1.0 cm² and/or mean tricuspid gradient \> 5 mmHg (assessed by the core laboratory).
•5. Tricuspid valve anatomy that cannot be evaluated by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
•6. 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).
•7. 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).
•8. Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg).
•9. 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 the core laboratory, would interfere with study device implantation or therapeutic effect, or where study device implantation would interfere with the pacemaker or ICD.
+20 more criteria

Locations (1)

Zhongshan Hospital, Fudan University

Shanghai, China

Key Dates

Start Date

January 28, 2026

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2031

Last Updated

February 25, 2026

Enrollment

132

ESTIMATED participants

Conditions

Severe or Greater Tricuspid Regurgitation

Interventions

Experimental: Transcatheter tricuspid valve repair using the transcatheter tricuspid valve clipping system +GDMT

DEVICE

Guideline Directed Medical Therapy

DRUG

Contacts

Tina Chen

CONTACT

+86-15986752781 tina.chen@hh-healthcare.com

Junbo Ge

CONTACT

021-60046990