Actively Recruiting
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Led by Shanghai Huihe Medical Technology Co., Ltd · Updated on 2022-06-28
10
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the effectiveness and safety of the transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Medical Technology Co., Ltd. for the treatment of patients with moderate-severe or worse tricuspid regurgitation
CONDITIONS
Official Title
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60 or older, regardless of gender
- Diagnosed with moderate-severe or worse tricuspid regurgitation (TR≥3+)
- Considered high risk for surgical operation by a multidisciplinary cardiac team (STS score > 6.0%) and likely to benefit from transcatheter tricuspid annulus repair
- Normal left ventricular function (LVEF≥40%)
- Voluntarily agrees to participate and signs informed consent (or guardian does)
You will not qualify if you...
- Pulmonary artery systolic pressure ≥ 55 mmHg
- Presence of prosthetic valve or annuloplasty ring at tricuspid valve or previous tricuspid valve-related treatment
- Evidence of lumps, thrombus, or vegetation in the heart, jugular vein, or superior vena cava
- Moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation
- Severe uncontrolled hypertension (systolic ≥ 180 mmHg and/or diastolic ≥ 110 mmHg)
- Percutaneous coronary intervention (PCI) less than 1 month ago
- Myocardial infarction or unstable angina pectoris less than 1 month ago
- Cerebrovascular accident less than 3 months ago
- Active endocarditis or active rheumatic heart disease
- Coagulation disorders, hypercoagulable state, or anemia (hemoglobin < 90 g/L)
- Acute or severe infections
- Active peptic ulcer or gastrointestinal bleeding
- Severe end-stage diseases with life expectancy less than 1 year
- Known allergies or contraindications to trial product materials or related drugs
- Addiction to alcohol, drugs, or narcotics
- Cognitive impairment preventing cooperation with the study
- History of epilepsy or mental illness
- Participation in other clinical trials (except registry studies) within 30 days prior to consent
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
S
Sally Yan, project supervisor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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