Tricuspid RegurgitationNCT05770648
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
A study testing Transcatheter Annuloplasty and The guidelines guide medication in people with Tricuspid Regurgitation, run by Shanghai Huihe Medical Technology Co., Ltd.
Trial 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. 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 and The guidelines guide medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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; (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.
Who cannot join
- 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;
Show all 28Show fewer
- 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;
- Patients with known allergy or contraindications to the raw material or drug (e.g. antiplatelet drugs, anticoagulants) of the test product;
- persons addicted to alcohol, drugs or drugs;
- Patients with cognitive impairment;
- A history of epilepsy or mental illness with primary and persistent seizures and poor drug control;
- Participate in any other clinical trial (other than a registered study) within 30 days prior to signing the informed consent;
- have had a pacemaker (other than a leadless pacemaker) or a defibrillator implanted in the past, or plan to have a pacemaker (other than a leadless pacemaker) or a defibrillator implanted;
- tricuspid stenosis;
- Ebstain syndrome;
- esophageal esophageal echocardiography (TEE) and Trans thoracic echocardiography (TTE) were not esophageal esophageal tricuspid ring anatomy;
- Hemodynamic instability;
- Patients with chronic dialysis;
- Women who have planned to become pregnant during pregnancy, lactation or clinical study;
- Other conditions for which the investigator considers it inappropriate to participate in the clinical trial.
About this study
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
- Being tested
- Transcatheter Annuloplasty, The guidelines guide medication
- 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 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.
The guidelines guide medicationOther
The guidelines guide medication
| Study group | Role | What they receive |
|---|---|---|
| K-clipTM transcatheter annuloplasty system+Guideline Directed Medical Therapy GDMT | Experimental | Not described Receives: Device: Transcatheter Annuloplasty |
| Guideline Directed Medical Therapy, GDMT | Other | Not described Receives: Other: The guidelines guide medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huihe Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770648
- Sponsor's protocol ID
- CSP-K-02
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05770648
- Acronym / sponsor ID
- CSP-K-02
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Huihe Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (28 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter AnnuloplastyUnder 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. | Device | K-clipTM transcatheter annuloplasty system+Guideline Directed Medical Therapy GDMT |
| The guidelines guide medicationThe guidelines guide medication | Other | Guideline Directed Medical Therapy, GDMT |
Primary outcome
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.
Time frame: Within 6 months of 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Annuloplasty and The guidelines guide medication 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 1 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
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?
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. (time frame: Within 6 months of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2023.