A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of the Transcatheter Tricuspid Valvuloplasty System in Patients With Severe or Above Tricuspid Regurgitation

NCT05770648 | Unknown

• 1 other identifier: CSP-K-02
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and safety of the transcatheter tricuspid valve ring system produced by Shanghai Huihe Medical Technology Co., Ltd. in the treatment of patients with severe or above tricuspid regurgitation who cannot be evaluated by clinicians for surgery.

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased ≥1+ within 6 months after randomization.

  The percentage of subjects with no all-cause death, no heart failure readmitted, NYHA increased by one grade or more, and TR decreased ≥1+ within 6 months after randomization.

  Within 6 months of randomization

Study Arms (2)

K-clipTM transcatheter annuloplasty system+Guideline Directed Medical Therapy GDMT

EXPERIMENTAL

Device: Transcatheter Annuloplasty

Guideline Directed Medical Therapy, GDMT

OTHER

Other: The guidelines guide medication

Interventions

Transcatheter Annuloplasty DEVICE

Under the guidance of ultrasound, the transcatheter tricuspid ring forming system accurately reaches the designated position of the tricuspid valve region through the jugular vein and superior vena cava approach. The expanded tricuspid ring tissue is clammed together with the clamping parts and anchor parts, and the circumference of the tricuspid ring is reduced, thus reducing the area of the opening of the tricuspid valve that cannot be closed originally, and achieving the purpose of minimally invasive treatment of tricuspid regurgitation.

K-clipTM transcatheter annuloplasty system+Guideline Directed Medical Therapy GDMT

The guidelines guide medication OTHER

The guidelines guide medication

Guideline Directed Medical Therapy, GDMT

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; (2) Patients with severe or above secondary tricuspid regurgitation (TR≥4+) (secondary tricuspid regurgitation: tricuspid regurgitation caused by right atrial disease, right ventricular cardiomyopathy, right ventricular myocardial infarction, left heart valve disease, congenital heart disease and other diseases); (3) A multidisciplinary cardiac team consisting of cardiovascular physicians, cardiovascular surgeons, imaging physicians, anesthesiologists, and at least 2 physicians considered the subjects to be at high risk for surgical procedures, i.e., EuroScore II was greater than 3.0%; (4) Left ventricular ejection fraction LVEF≥30%; (5) The subject voluntarily participates in the clinical trial and agrees or his guardian agrees to sign the informed consent; (6) Symptoms of tricuspid regurgitation, such as chest tightness, asthma, shortness of breath, lower limb edema, ascites; (7) NYHA Grades 2 to 4, including Grades 2 and 4; (8) The optimal drug treatment for tricuspid valve ≥ 30 days and the patient's state was stable; (9) Patients with mitral regurgitation, atrial fibrillation, coronary artery disease, and heart failure should be treated for ≥ 30 days with medication or ≥ 30 days after instrument therapy and in stable condition.

You may not qualify if:

• Patients with pure organic (i.e. primary) tricuspid regurgitation;
• Patients with pulmonary artery systolic blood pressure ≥60 mmHg;
• Patients with tricuspid valve prosthesis or plastic ring, or patients with tricuspid valve-related surgery;
• Patients with retrotricuspid annulus calcification;
• Evidence of intracardiac, jugular and superior vena cava masses, thrombus or growths;
• Patients with more than moderate aortic 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);
• Percutaneous coronary intervention within 1 month;
• Myocardial infarction or known unstable angina within the previous 1 month;
• cerebrovascular accidents occurred within the previous 3 months;
• Patients with active endocarditis or active rheumatic heart disease;
• Patients with coagulopathy, hypercoagulability or anemia (hemoglobin \< 90 g/L);
• Patients in the acute infection stage or other severe infections;
• Patients with active peptic ulcer or active gastrointestinal bleeding;
• severe end-stage diseases (such as malignant tumors, severe lung diseases, liver diseases, renal failure) with a life expectancy of less than 1 year;

Sponsors & Collaborators

• Shanghai Huihe Medical Technology Co., Ltd: lead

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: March 15, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 15, 2023

Record last verified: 2023-03