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Tricuspid RegurgitationTriStarNCT05173233

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

A study testing Transcatheter Annuloplasty in people with Tricuspid Regurgitation, run by Shanghai Huihe Medical Technology Co., Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Tricuspid Regurgitation
What is being tested?
Transcatheter Annuloplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
No sites listed yet
Study dates
15 May 2022to 15 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • Patients with known allergies or contraindications to the raw materials or drugs (such as antiplatelet drugs and anticoagulants) of the test products;
  • Persons addicted to alcohol, drugs or drugs;
  • Patients with cognitive impairment;
  • patients with histories of epilepsy or mental illness;
  • Participate in any other clinical trial (other than a registry study) within 30 days prior to signing the informed consent;
  • have a previous implantation of a pacemaker or defibrillator, or plan to implant a pacemaker or defibrillator;
  • Tricuspid stenosis;
  • Ebstain syndrome;
  • The anatomy of tricuspid annulus could not be assessed by TEE and TTE;
  • Hemodynamic instability;
  • chronic dialysis patients;
  • women who are pregnant during pregnancy, breast-feeding or during the clinical study;
  • Other conditions that the investigator considers inappropriate for participation in the clinical trial.

About this study

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.

Being tested
Transcatheter Annuloplasty
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter AnnuloplastyDevice

    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.

Study groups in NCT05173233
Study groupRoleWhat they receive
K-clipTM transcatheter annuloplasty systemExperimentalNot described
Receives: Device: Transcatheter Annuloplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 1-year after operation

  2. Change of Tricuspid Regurgitation Grade

    Change of Tricuspid Regurgitation Grade assessed by corelab than baseline

    Measured: 1-year after operation

Secondary outcomes (7)

  1. The success rate of post operation 12 months

    Measured: 2 years, 3years, 4 years, 5 years

  2. Success rate of device implantation

    Measured: intra-procedure

  3. Change in echocardiographic parameters

    Change in echocardiographic parameters：Tricuspid annulus A-P diameter（mm）、 Tricuspid annulus perimeter（mm）、Tricuspid annulus area(cm2)、Vena contracta width（mm）、EROA(cm2)、Regurgitation volume(ml)、IVC(mm)。

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

  4. Change of Tricuspid Regurgitation Grade

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

  5. NYHA

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

  6. 6 minutes walk distance

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

  7. Kansas City Cardiomyopathy Questionnaire (KCCQ)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2021
  2. Study start15 May 2022 (estimated)
  3. Primary completion15 May 2023 (estimated)
  4. Study completion15 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05173233
Sponsor's protocol ID
HH2021003
Acronym
TriStar
Status last verified
Apr 2022
First submitted
27 Dec 2021
Last updated
21 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 39663060

  • 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.

    PubMed 38938712

  • 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.

    PubMed 36517335

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Annuloplasty in people with Tricuspid Regurgitation, run by Shanghai Huihe Medical Technology Co., Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 1-year after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05173233, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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