Clinical trial NCT05434507: Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
Official title: Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Lead sponsor: Shanghai Huihe Medical Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 or worse tricuspid regurgitation


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.

Primary outcomes:
measure: Success rate 1year after operation
timeFrame: 1-year after operation
measure: Success rate of operation
timeFrame: intra-procedure
measure: Success rate of device implantation
timeFrame: intra-procedure
measure: Change in echocardiographic parameters
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: Change in echocardiographic parameters
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: Change of Tricuspid Regurgitation Grade
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: NYHA Functional Class
timeFrame: 30 days, 6 Months, 12 Months, annual for five years
measure: 6 minutes walk distance
timeFrame: 1 month, 6 months,12 Months
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: 30 days, 6 Months, 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Huihe Healthcare Tecnology Co.,Ltd.
state: Shanghai
Study officials:
References: