Actively Recruiting
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.
Led by Shanghai Huihe Medical Technology Co., Ltd · Updated on 2026-02-25
132
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Severe or greater tricuspid regurgitation (TR ≥ 4+) with stable condition for at least 30 days
- Stable oral diuretic therapy for tricuspid regurgitation and guideline-directed medical therapy for heart failure for at least 30 days
- Judged by a heart team to be at moderate or high surgical risk (Tri-Score ≥ 4.0) and expected to benefit from edge-to-edge tricuspid repair
- Left ventricular ejection fraction (LVEF) ≥ 20%
- Presence of symptoms related to tricuspid regurgitation or asymptomatic with right ventricular dilation or impaired function
- Impaired right ventricular function defined as TAPSE < 17 mm or FAC < 35%
- NYHA functional class II to IV
- Voluntary agreement to participate with written informed consent
You will not qualify if you...
- Pulmonary artery systolic pressure ≥ 60 mmHg
- Tricuspid valve anatomy unsuitable for clip implantation or adequate repair
- Presence of prosthetic valve or prior tricuspid surgery interfering with device placement
- Tricuspid stenosis with valve area ≤ 1.0 cm² or mean gradient > 5 mmHg
- Inability to evaluate tricuspid valve anatomy by echocardiography
- Presence of mass, thrombus, or vegetation in heart chambers or access veins
- Unsuitable femoral or jugular veins for device access
- Severe uncontrolled hypertension (≥ 180/110 mmHg)
- Prior or planned pacemaker or ICD implantation interfering with study device
- Hemodynamic instability or cardiogenic shock
- End-stage refractory heart failure requiring specialized interventions
- More than moderate aortic or mitral valve disease or planned cardiac surgery within 12 months
- Recent percutaneous coronary intervention or myocardial infarction
- Recent cerebrovascular accident
- Active infective endocarditis or rheumatic heart disease
- Coagulopathy, anemia (hemoglobin < 90 g/L), or severe infection
- Active peptic ulcer or gastrointestinal bleeding
- Recent transient ischemic attack or stroke with severe disability
- Severe end-stage diseases with life expectancy under 1 year
- Hypersensitivity to device materials or study medications
- Substance addiction or cognitive impairment
- Poorly controlled epilepsy or psychiatric disorders
- Participation in another clinical trial within 30 days
- Chronic dialysis treatment
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, China
Actively Recruiting
Research Team
T
Tina Chen
CONTACT
J
Junbo Ge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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