Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System

Recruiting now · Not applicable

Conditions studied: Tricuspid Regurgitation

In brief

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

Key facts

Study ID

NCT05434507

Run by

Shanghai Huihe Medical Technology Co., Ltd

People needed

10

Starts

2021-09-16

Expected to finish

2026-09-16

Last updated by the study team

2022-06-28

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Huihe Healthcare Tecnology Co.,Ltd. — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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