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

NCT05434507 | Recruiting

• 1 other identifier: HH2021002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

K-clipTM transcatheter annuloplasty system

EXPERIMENTAL

Device: Transcatheter Annuloplasty

Interventions

Transcatheter Annuloplasty DEVICE

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.

K-clipTM transcatheter annuloplasty system

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Shanghai Huihe Medical Technology Co., Ltd: lead

Study Sites (1)

Shanghai Huihe Healthcare Tecnology Co.,Ltd.

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sally Yan, project supervisor

CONTACT

18800263183; Sally.yan@hh-healthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2022
• First Posted: June 28, 2022
• Study Start: September 16, 2021
• Primary Completion (Estimated): September 16, 2026
• Study Completion (Estimated): September 16, 2026
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CN (1)