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NCT Number: NCT05434507

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

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

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Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Huihe Healthcare Tecnology Co.,Ltd.

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Sally Yan

CONTACT

[email protected]

18800263183

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Patients with cognitive impairment who cannot cooperate with the study or follow-up;
  • Those with a history of epilepsy or mental illness;
  • Participated in any other clinical trials (except for registry studies) less than 30 days before the signing the informed consent form;
  • Other situations that the investigator considers inappropriate for participation in this clinical trial.

Treatment and study plan

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.

Primary outcomes

  1. Success rate 1year after operation

    Time frame: 1-year after operation

  2. Success rate of operation

    Time frame: intra-procedure

  3. Success rate of device implantation

    Time frame: intra-procedure

  4. Change in echocardiographic parameters

    Time frame: 30 days, 6 Months, 12 Months, annual for five years

    Tricuspid annulus perimeter（mm）

  5. Change in echocardiographic parameters

    Time frame: 30 days, 6 Months, 12 Months, annual for five years

    Tricuspid annulus area(mm2)

  6. Change of Tricuspid Regurgitation Grade

    Time frame: 30 days, 6 Months, 12 Months, annual for five years

    Number of patients with reduction in TR from baseline

  7. NYHA Functional Class

    Time frame: 30 days, 6 Months, 12 Months, annual for five years

    Number of patients with improvement in NYHA class

  8. 6 minutes walk distance

    Time frame: 1 month, 6 months,12 Months

    Increase in distance (m) from baseline

  9. Kansas City Cardiomyopathy Questionnaire

    Time frame: 30 days, 6 Months, 12 Months

    Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Sally Yan, project supervisor

CONTACT

[email protected]

18800263183

Sponsors and collaborators

Lead sponsor

Shanghai Huihe Medical Technology Co., Ltd

Industry

Registry information

Official study title

Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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