Treating tricuspid regurgitation with a new transcatheter system

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

This study is testing a new device to see if it can safely help older patients with serious tricuspid regurgitation feel better without major surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 60 Years to 90 Years
• Sex: All
• Sponsor: Shanghai Huihe Medical Technology Co., Ltd (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05434507 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of the K-ClipTM transcatheter annuloplasty system for patients suffering from moderate-severe or worse tricuspid regurgitation. The trial focuses on individuals aged 60 and older who are considered high-risk for surgical intervention. A multidisciplinary cardiac team will assess the patients to determine their eligibility and potential benefit from the treatment. The intervention involves a minimally invasive procedure aimed at repairing the tricuspid valve.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 or older with moderate-severe tricuspid regurgitation who are at high surgical risk.

Not a fit: Patients with pulmonary artery hypertension or those who have previously undergone tricuspid valve-related procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer alternative for high-risk patients with tricuspid regurgitation, potentially improving their quality of life.

How similar studies have performed: While this approach is relatively novel, similar transcatheter interventions have shown promise in treating other heart valve conditions.

Eligibility criteria

Inclusion Criteria:

1. Aged 60 or older, regardless of gender;
2. Patients with moderate-severe or worse tricuspid regurgitation (TR≥3+);
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;
4. Patient with normal left ventricular function (LVEF≥40%);
5. The subject voluntarily participates in the clinical trial and he/she (or his/her guardian) agrees to sign the informed consent form.

Exclusion Criteria:

1. Patients with pulmonary artery systolic pressure ≥55 mmHg;
2. Patients who have a prosthetic valve or annuloplasty ring at tricuspid valve, or who underwent tricuspid valve-related treatment procedure in the past;
3. Evidence of lumps, thrombus or vegetation in the heart, jugular vein, or superior vena cava;
4. Patients with moderate or worse aortic valve stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
5. Patients with severe uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
6. Received PCI less than 1 month ago;
7. MI happened or UAP was found less than 1 month ago;
8. CVA occurred less than 3 months ago;
9. Patients with comorbid active endocarditis or active RHD;
10. Patients with coagulation disorder, hypercoagulable state or anemia (HGB \< 90 g/L);
11. Patients with acute infection or other severe infections;
12. Patients with active peptic ulcer or active gastrointestinal bleeding;
13. 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;
14. Patients with known allergies or contraindications to the raw materials of trial product or the drugs (e.g., antiplatelet drugs, anticoagulant drugs);
15. People who are addicted to alcohol, drugs or narcotics;
16. Patients with cognitive impairment who cannot cooperate with the study or follow-up;
17. Those with a history of epilepsy or mental illness;
18. Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
19. Other situations that the investigator considers inappropriate for participation in this clinical trial.

Where this trial is running

Shanghai, Shanghai Municipality

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

Study contacts

• Study coordinator: Sally Yan, project supervisor

Conditions Tricuspid Regurgitation