Confirmatory Clinical Study of Treating Tricuspid Regurgitation With K-Clip TM Transcatheter Annuloplasty System

NCT05173233 | Not Yet Recruiting

• 1 other identifier: HH2021003
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

Brief Summary

The present clinical trial is performed to evaluate the effectiveness and safety of transcatheter tricuspid annuloplasty system manufactured by Shanghai Huihe Healthcare technology Co.,Ltd. for the treatment of subjects with severe or worse tricuspid regurgitation.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  1-year after operation

• Change of Tricuspid Regurgitation Grade

  Change of Tricuspid Regurgitation Grade assessed by corelab than baseline

  1-year after operation

Secondary Outcomes (7)

• The success rate of post operation 12 months

  2 years, 3years, 4 years, 5 years

• Success rate of device implantation

  intra-procedure

• Change in echocardiographic parameters

  1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years

• Change of Tricuspid Regurgitation Grade

  1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years

• NYHA

  1 month, 6 months, 1 year, 2 years, 3years, 4 years, 5 years

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

You may qualify if:

• Age ≥60, male or female;
• patients with severe or above secondary tricuspid regurgitation (TR≥4+) (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial lesions, right ventricular cardiomyopathy, right ventricular myocardial infarction, left ventricular valvular disease, congenital heart disease and other diseases);
• A multidisciplinary cardiac team (at least 2 doctors) consisting of cardiovascular physicians, cardiovascular surgeons, radiologists, anesthesiologists, etc., considered the subject to be at high risk for surgery and expected to benefit from tricuspid valve repair;
• Left ventricular ejection fraction LVEF≥40%;
• The subject voluntarily participates in the clinical trial and agrees or his/her guardian agrees to sign the informed consent.
• Tricuspid regurgitation symptoms, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites;
• NYHA grade 2 to 4;
• Patients who received tricuspid valve optimal drug therapy for ≥ 30 days were in stable condition;
• In the case of the following diseases: mitral regurgitation, atrial fibrillation, coronary disease and heart failure, drug treatment should be ≥ 30 days or ≥ 30 days after instrumental treatment and the patient's condition is stable.

You may not qualify if:

• patients with primary tricuspid regurgitation;
• Patients with systolic pulmonary artery pressure ≥55 mmHg;
• Patients with tricuspid valve or annuloplasty or tricuspid related procedure;
• Patients with posterior tricuspid annulus calcification;
• Evidence of mass, thrombosis or vegetations in the heart, jugular vein and superior vena cava;
• patients with moderate or higher aortic stenosis, mitral stenosis, aortic regurgitation or mitral regurgitation;
• patients with severely uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
• Percutaneous coronary intervention within 1 month;
• myocardial infarction or known unstable angina within 1 month;
• Cerebrovascular accident within the past 3 months;
• patients with active endocarditis or active rheumatic heart disease;
• Patients with coagulation dysfunction, hypercoagulability or anemia (hemoglobin \< 90 g/L);
• patients with acute infection or other severe infection;
• Patients with active peptic ulcer or active gastrointestinal bleeding;
• severe end-stage diseases (such as malignant tumor, severe lung disease, liver disease, renal failure) with a life expectancy of less than one year;

Sponsors & Collaborators

• Shanghai Huihe Medical Technology Co., Ltd: lead

Related Publications (3)

• Xu H, Chen M, Wang Z, Huo J, Li J, He F, Husanova F, Li H, Zhou D, Zhang X, Liu X, Song G, Li J, Luo J, Guo Y, Mou Y, Yuan S, Tao T, Wu S, Teng P, Ni Y, Ma L, Pan X, Ge J, Lee AP, Li W. Mid-Term Outcomes of K-Clip Transcatheter Tricuspid Annuloplasty System in Patients With Severe Functional Tricuspid Regurgitation. JACC Cardiovasc Interv. 2024 Dec 9;17(23):2796-2807. doi: 10.1016/j.jcin.2024.10.007.

  PMID: 39663060 DERIVED

• Xu H, Li W, Lee AP, Wu S, Husanova F, Wu B, Mou Y, Gu Y, Chen M, Tao T, Zhang Y, Zheng J, Yang A, Yuan S, Wang Q, Ni Y, Ma L. 30-Day Outcomes of Transcatheter Tricuspid Annuloplasty With the K-Clip System: A Single-Center, Observational Study. JACC Adv. 2023 Oct 27;2(9):100671. doi: 10.1016/j.jacadv.2023.100671. eCollection 2023 Nov.

  PMID: 38938712 DERIVED

• Wollborn J, Schuler A, Sheu RD, Shook DC, Nyman CB. Real-Time Multiplanar Reconstruction Imaging Using 3-Dimensional Transesophageal Echocardiography in Structural Heart Interventions. J Cardiothorac Vasc Anesth. 2023 Apr;37(4):570-581. doi: 10.1053/j.jvca.2022.11.011. Epub 2022 Nov 13.

  PMID: 36517335 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

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: December 27, 2021
• First Posted: December 29, 2021
• Study Start: May 15, 2022
• Primary Completion: May 15, 2023
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share