Tricuspid RegurgitationNCT05434507
Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter Annuloplasty System
A study testing Transcatheter Annuloplasty in people with Tricuspid Regurgitation, run by Shanghai Huihe Medical Technology Co., Ltd at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 60 to 90 years
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2021to 16 Sep 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Huihe Healthcare Tecnology Co.,Ltd.
Shanghai, Shanghai Municipality, 200000
Sally Yan, 18800263183, sally.yan@hh-healthcare.com
About this study
Official title: Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter
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
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| K-clipTM transcatheter annuloplasty system | Experimental | Not described Receives: Device: Transcatheter Annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate 1year after operation
Measured: 1-year after operation
Success rate of operation
Measured: intra-procedure
Success rate of device implantation
Measured: intra-procedure
Change in echocardiographic parameters
Tricuspid annulus perimeter（mm）
Measured: 30 days, 6 Months, 12 Months, annual for five years
Change in echocardiographic parameters
Tricuspid annulus area(mm2)
Measured: 30 days, 6 Months, 12 Months, annual for five years
Change of Tricuspid Regurgitation Grade
Number of patients with reduction in TR from baseline
Measured: 30 days, 6 Months, 12 Months, annual for five years
NYHA Functional Class
Number of patients with improvement in NYHA class
Measured: 30 days, 6 Months, 12 Months, annual for five years
6 minutes walk distance
Increase in distance (m) from baseline
Measured: 1 month, 6 months,12 Months
Kansas City Cardiomyopathy Questionnaire
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
Measured: 30 days, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start16 Sep 2021
- Primary completion16 Sep 2026 (estimated)
- Study completion16 Sep 2026 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05434507
- Sponsor's protocol ID
- HH2021002
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 28 Jun 2022
- 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 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Treating Tricuspid Regurgitation With K-ClipTM Transcatheter
- ClinicalTrials.gov ID
- NCT05434507
- Acronym / sponsor ID
- HH2021002
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Huihe Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 28 Jun 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-clipTM transcatheter annuloplasty system | Experimental | Device: Transcatheter Annuloplasty |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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);
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 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. | Device | K-clipTM transcatheter annuloplasty system |
Primary outcome
Success rate 1year after operation
Time frame: 1-year after operation
Success rate of operation
Time frame: intra-procedure
Success rate of device implantation
Time frame: intra-procedure
Change in echocardiographic parameters
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Tricuspid annulus perimeter（mm）
Change in echocardiographic parameters
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Tricuspid annulus area(mm2)
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
NYHA Functional Class
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Number of patients with improvement in NYHA class
6 minutes walk distance
Time frame: 1 month, 6 months,12 Months
Increase in distance (m) from baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
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 at 1 site in China.
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 5 inclusion and 19 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 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Sally Yan, project supervisor (18800263183, Sally.yan@hh-healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate 1year after operation (time frame: 1-year after operation). The study lists 9 primary outcomes in all. 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 28 Jun 2022.