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

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

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

Study Overview

• Status: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Annuloplasty

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sally Yan, project supervisor; Phone Number: 18800263183; Email: Sally.yan@hh-healthcare.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Huihe Healthcare Tecnology Co.,Ltd.
      • Contact: Sally Yan; Phone Number: 18800263183; Email: sally.yan@hh-healthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: K-clipTM transcatheter annuloplasty system

Device: Transcatheter Annuloplasty; Under echocardiography guidance, the transcatheter tricuspid annuloplasty system precisely reaches the specified position in the tricuspid valve region via jugular vein and superior vena cava approach. The enlarged tricuspid annular tissue is clamped with the clamp cpart and anchor part to reduce the perimeter of tricuspid annulus, so that the area of tricuspid orifice that could not be coapted is reduced. It plays the purpose of minimally invasive treatment of tricuspid valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate 1year after operation		1-year after operation
Success rate of operation		intra-procedure
Success rate of device implantation		intra-procedure
Change in echocardiographic parameters	Tricuspid annulus perimeter（mm）	30 days, 6 Months, 12 Months, annual for five years
Change in echocardiographic parameters	Tricuspid annulus area(mm2)	30 days, 6 Months, 12 Months, annual for five years
Change of Tricuspid Regurgitation Grade	Number of patients with reduction in TR from baseline	30 days, 6 Months, 12 Months, annual for five years
NYHA Functional Class	Number of patients with improvement in NYHA class	30 days, 6 Months, 12 Months, annual for five years
6 minutes walk distance	Increase in distance (m) from baseline	1 month, 6 months,12 Months
Kansas City Cardiomyopathy Questionnaire	Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire	30 days, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: Shanghai Huihe Medical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Anticipated): September 16, 2026
• Study Completion (Anticipated): September 16, 2026

Study Registration Dates

• First Submitted: June 12, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID Numbers: HH2021002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No