Status:
RECRUITING
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Lead Sponsor:
Shanghai Huihe Medical Technology Co., Ltd
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
60-90 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Aged 60 or older, regardless of gender;
- Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
- The multidisciplinary cardiac team (composed of experts in cardiovascular internal medicine and surgery, imaging, anesthesiology, etc. \[No. of experts in cardiovascular surgery \>=2\]) considers the subjects to be at high risk for surgical operation (STS score \> 6.0%) and expects that they will benefit from the transcatheter tricuspid annulus repair;
- Patient with normal left ventricular function (LVEF≥40%);
- The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.
Exclusion
- Patients with pulmonary artery systolic pressure ≥55 mmHg;
- Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
- Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
- Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
- Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Received PCI less than 1 month ago;
- MI happened or UAP was found less than 1 month ago;
- CVA occurred less than 3 months ago;
- Patients with comorbid active endocarditis or active RHD;
- Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);
- Patients with acute infection or other severe infections;
- Patients with active peptic ulcer or active gastrointestinal bleeding;
- Patients with severe end-stage diseases (e.g., malignant tumors, severe pulmonary diseases, hepatic diseases, renal failure) whose life expectancy is less than 1 year;
- Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
- People who are addicted to alcohol, drugs or narcotics;
- Patients with cognitive impairment who cannot cooperate with the study or follow-up;
- Those with a history of epilepsy or mental illness;
- Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
- Other situations that the investigator considers inappropriate for participation in this clinical trial.
Key Trial Info
Start Date :
September 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 16 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05434507
Start Date
September 16 2021
End Date
September 16 2026
Last Update
June 28 2022
Active Locations (1)
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1
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Shanghai, Shanghai Municipality, China, 200000