Tricuspid RegurgitationNCT06605313
SQ-Kyrin-T First-in-man Feasibility Study
A study testing SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System in people with Tricuspid Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery; and to provide safety and efficacy data… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2022to 24 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe or greater (≥3+) tricuspid regurgitation determined by transthoracic echocardiogram despite adequate treatment per applicable standards.
- NYHA classification of II, III, or IVa.
- Age ≥ 18 years old, gender not limited.
- Patient is determined to be at high or prohibitive risk for tricuspid valve surgery, or is determined to be not suitable for open heart surgery by local multidisciplinary cardiac team (with at least one cardiac surgeon and one cardiologist).
- Patients who understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant examinations and clinical follow-up.
- Tricuspid valve coaptation defect<2cm.
- No significant calcification of tricuspid valve leaflets.
- Tricuspid valve leaflet anatomy suitable for clip implantation, positioning on the leaflets and sufficient reduction in TR.
Who cannot join
- Previous tricuspid valve surgery; previous heart transplant; implanted cardiac electronic device.
- Any cardiovascular interventional procedure within the past 30 days.
- Patients with other valvular diseases requiring surgical or interventional treatment.
- Patients with severe large-vessel disease requiring surgical treatment.
- Echocardiogram indicating the presence of intracardiac masses, thrombus, or vegetations.
- Severe uncontrolled hypertension (systolic blood pressure [SBP] ≥ 180 mmHg and/or diastolic blood pressure [DBP] ≥ 110 mmHg).
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- Pulmonary artery systolic pressure > 70 mmHg.
- Moderate to severe or severe mitral regurgitation (≥3+).
- Active infective endocarditis, active rheumatic heart disease, or rheumatic tricuspid valve disease.
- Myocardial infarction or known unstable angina within the past 30 days.
- Severe untreated coronary artery disease.
- Hemodynamic instability, defined as SBP < 90 mmHg with or without cardiogenic shock, or the need for an intra-aortic balloon pump or other hemodynamic support device.
- Cerebrovascular accident within the past 3 months.
- Renal failure requiring dialysis.
- Patients with a confirmed coagulation disorder or severe coagulation system disease.
- Patients with clear contraindications to anticoagulant use.
- History of acute peptic ulcer or gastrointestinal bleeding within the past 3 months.
- Known allergy to contrast agents or nickel-titanium alloy products.
- Tricuspid valve stenosis (defined as a tricuspid valve area ≤ 1.0 cm² and/or a mean trans-tricuspid gradient ≥ 5 mmHg).
- Left ventricular ejection fraction (LVEF) ≤ 20%.
- Severe chronic obstructive pulmonary disease requiring continuous oxygen therapy.
- Life expectancy of less than 12 months.
- Pregnant or breastfeeding women, or women planning to conceive.
- Patients deemed to have poor compliance or unable to complete the study as required; or other situations in which the investigator considers the subject unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Cardiovascular Hospital of Yunnan Province
Kunming, Yunnan, 650102
About this study
Official title: First-in-man Feasibility Study of SQ-Kyrin-T Transcatheter Tricuspid Valve Clip Delivery System and Steerable Guide Catheter in Patients With Severe Tricuspid Regurgitation
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery; and to provide safety and efficacy data on which subsequent confirmatory trial can be based.
Read the detailed description
A prospective, multicenter, single-arm feasibility trial to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery.
It plans to enroll 12 qualified patients. The primary endpoint of the study is the postoperative technical success rate. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
- Conditions
- Tricuspid Regurgitation
- Being tested
- SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System
- 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.
SQ-Kyrin-T Transcatheter Tricuspid Valve Repair SystemDevice
Transcathether Edge-to-Edge repair for tricuspid regurgitation with SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System.
| Study group | Role | What they receive |
|---|---|---|
| SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System | Experimental | Subjects who received treatment with the experimental device will be included in this arm. Receives: Device: SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate
Defined by the following four conditions:
- No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.
Measured: immediately after intervention
Secondary outcomes (4)
Incidence of all-cause mortality
Measured: 30 days
Incidence of major adverse events
The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or interventional-related adverse events that occurred since successful transfemoral vein puncture and establishment of atrial septal pathway.
Measured: 30 days
Device success rate
Defined by the following two conditions:
- Technical success maintained at day 30. 2. Echocardiographic tricuspid regurgitation reduction at least 1 grade.
Measured: 30 days
Clinical success rate
Defined by following two conditions:
- Device success. 2. No major adverse events occurred.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start16 Jun 2022
- Primary completion7 Dec 2022
- Study completion24 Nov 2027 (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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiangbin Pan, MD, Ph.D, Principal investigator, Fuwai Cardiovascular Hospital of Yunnan Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605313
- Sponsor's protocol ID
- TVRP01-001
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Feasibility Study of SQ-Kyrin-T Transcatheter Tricuspid Valve Clip Delivery System and Steerable Guide Catheter in Patients With Severe Tricuspid Regurgitation
- ClinicalTrials.gov ID
- NCT06605313
- Acronym / sponsor ID
- TVRP01-001
- Conditions
- Tricuspid Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 24 Nov 2027 (estimated)
- First posted
- 20 Sep 2024 (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.
The goal of this clinical trial is to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery; and to provide safety and efficacy data on which subsequent confirmatory trial can be based.
Detailed description
A prospective, multicenter, single-arm feasibility trial to evaluate the performance, operability and reliability of the SQ-Kyrin-T Transcatheter Edge-to Edge Valve Repair System in treating severe tricuspid regurgitation in Chinese population with high or prohibitive risk for conventional surgery.
It plans to enroll 12 qualified patients. The primary endpoint of the study is the postoperative technical success rate. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System | Experimental | Device: SQ-Kyrin-T Transcatheter Tricuspid Valve Repair SystemSubjects who received treatment with the experimental device will be included in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Severe or greater (≥3+) tricuspid regurgitation determined by transthoracic echocardiogram despite adequate treatment per applicable standards.
- NYHA classification of II, III, or IVa.
- Age ≥ 18 years old, gender not limited.
- Patient is determined to be at high or prohibitive risk for tricuspid valve surgery, or is determined to be not suitable for open heart surgery by local multidisciplinary cardiac team (with at least one cardiac surgeon and one cardiologist).
- Patients who understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant examinations and clinical follow-up.
Key exclusion criteria (24 listed)
- Previous tricuspid valve surgery; previous heart transplant; implanted cardiac electronic device.
- Any cardiovascular interventional procedure within the past 30 days.
- Patients with other valvular diseases requiring surgical or interventional treatment.
- Patients with severe large-vessel disease requiring surgical treatment.
- Echocardiogram indicating the presence of intracardiac masses, thrombus, or vegetations.
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 |
|---|---|---|
| SQ-Kyrin-T Transcatheter Tricuspid Valve Repair SystemTranscathether Edge-to-Edge repair for tricuspid regurgitation with SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System. | Device | SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System |
Primary outcome
Technical success rate
Time frame: immediately after intervention
Defined by the following four conditions: 1. No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.
4 secondary outcomes
Incidence of all-cause mortality
Time frame: 30 days
Incidence of major adverse events
Time frame: 30 days
Device success rate
Time frame: 30 days
Clinical success rate
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Xiangbin Pan, MD, Ph.D principal investigator
Fuwai Cardiovascular Hospital of Yunnan Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQ-Kyrin-T Transcatheter Tricuspid Valve Repair System in people with Tricuspid Regurgitation, run by Shanghai Shenqi 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 8 inclusion and 24 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: under way, not looking for participants, as of the sponsor's last update on 20 Sep 2024. 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?
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?
Technical success rate (time frame: immediately after intervention). 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 20 Sep 2024.