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Functional Mitral RegurgitationNCT05988450

Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation

A study testing SQ-Kyrin Transcatheter Mitral Valve Repair System in people with Functional Mitral Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Mitral Regurgitation
What is being tested?
SQ-Kyrin Transcatheter Mitral Valve Repair System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteChina
Study dates
7 Mar 2022to Dec 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 functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);
  • Note: Eligible TTE must be obtained at least 30 days after the subject has been stabilized on optimal therapy (including Guideline Directed Medical Therapy GDMT). In the judgment of the center's cardiac team, subjects have received adequate treatment according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, MR, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), implantable cardioverter-defibrillator (ICD) implantation, coronary revascularization, and stable GDMT (see Appendix III for the definition of GDMT).
  • Age ≥ 18 years old, regardless of gender;
  • Cardiac function classification NYHA class II, III or ambulatory IV a;
  • At least one hospitalization for heart failure or subjects with high BNP > 150 pg/ml or high NT-proBNP > 600 pg/ml in the past 12 months.
  • Note: BNP or NT-proBNP must be obtained after the subject has stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) at least 30 days. The patients can understand the purpose of the trial, voluntarily participate and sign an informed consent form, and are willing to undergo relevant tests and clinical follow-up.
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  • Left ventricular end-systolic diameter (LVESD)≤70mm
  • The MR beam mainly originates from the A2/P2 area
  • Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>10mm
  • Mitral valve effective orifice area (EOA) ≥ 4.0cm2

Who cannot join

  • History of mitral valve surgery;
  • Patients with infective endocarditis or suggestive of active infection;
  • Complicated with severe untreated coronary artery disease;
  • Patients with pulmonary hypertension (pulmonary systolic blood pressure>70mmHg);
  • patients with transthoracic echocardiographic evidence of moderate-severe to severe right ventricular dysfunction;
  • Left heart ejection fraction <20%;
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  • Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
  • Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
  • Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
  • Patients with definite coagulation disorders and severe coagulation system diseases;
  • Patients with clear contraindications to the use of anticoagulants;
  • Patients with stroke or transient cerebral ischemic attack within 30 days;
  • Received cardiac pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implanted cardioverter-defibrillator (ICD) implantation therapy within 30 days;
  • Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic echocardiography;
  • Severe tricuspid TR;
  • Patients with other valve disease requiring surgery or interventional therapy;
  • Patients with severe macrovascular disease requiring surgical treatment;
  • Severe symptomatic carotid stenosis (>70% on ultrasonography) or carotid stenting within 30 days;
  • Patients with inappropriate anatomical structures of the heart and valves indicated by imaging examinations;
  • Known allergy to contrast agents and nickel-titanium memory alloy products;
  • <Resting systolic blood pressure 90 mmHg or >160 mmHg;
  • Patients with diseases that seriously affect the evaluation of treatment, such as patients with severe neurological lesions affecting cognitive ability, patients with malignant tumors, etc.;
  • Patient life expectancy < 12 months;
  • Patients with severe thoracic deformity;
  • Women who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of Northern Theater Command, PLA

    Shenyang, Liaoning, 123005

Other trials in China

About this study

Official title: A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.

Read the detailed description

This study is a prospective, multi-center, single arm clinical study designed to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR (Functional MR) who still have symptoms after adequate treatment. This trial will be conducted at 41 sites in China and is planned to include a total of 118 subjects. All subjects received the trial device for transcatheter mitral valve clip delivery system and steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after surgery. The composite endpoint of all-cause death and hospitalization for heart failure was assessed at 12 months after surgery. After the 12th month follow-up, the statistical analysis, clinical summary and application for product registration were carried out.

Being tested
SQ-Kyrin Transcatheter Mitral Valve Repair System
Keywords
Functional Mitral Regurgitation, Mitral Regurgitation
Medical subject headings
Mitral Valve Insufficiency

What participants receive

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

  • SQ-Kyrin Transcatheter Mitral Valve Repair SystemDevice

    Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

Study groups in NCT05988450
Study groupRoleWhat they receive
SQ-Kyrin TMVr SystemExperimentalTranscatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.
Receives: Device: SQ-Kyrin Transcatheter Mitral Valve Repair System

What is being measured

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

  1. Rate of all-cause death and hospitalization for heart failure

    Freefrom of all-cause death and hospitalization for heart failure

    Measured: 12 months

Secondary outcomes (9)

  1. Technical success rate

    1. No surgical death
    2. Delivery system for successful delivery and retrieval of devices
    3. Successful devices release and accurate positioning
    4. No need for any emergency surgery related to the device or surgical approach

    Measured: Immediate postoperative

  2. Device success rate

    1. Successfully implanted valve clip
    2. Transthoracic echocardiographic assessment showing MR ≤2+

    Measured: 30 days after surgery

  3. Surgical success rate

    1. Device success
    2. No major adverse events occurred The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or surgery-related adverse events following the atrial septum pathway via the femoral vein.

    Measured: 30 days after surgery

  4. Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;

    Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;

    Measured: 30 days, 6 months, and 12 months after surgery

  5. Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;

    Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;

    Measured: 30 days, 6 months, and 12 months after surgery

  6. The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;

    The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;

    Measured: 30 days, 6 months, and 12 months after surgery

  7. Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);

    Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);

    Measured: 12 months after surgery

  8. Improvement in 6-minute walk distance from baseline at 12 months after surgery;

    Improvement in 6-minute walk distance from baseline at 12 months after surgery;

    Measured: 12 months after surgery

  9. Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;

    Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;

    Measured: 12 months after surgery

Timeline

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

  1. First posted14 Aug 2023
  2. Study start7 Mar 2022
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 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
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05988450
Sponsor's protocol ID
MVRP01-001A
Status last verified
Aug 2023
First submitted
4 Aug 2023
Last updated
14 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xu K, Zhu D, Jiang H, Chen J, Chen S, Zhang J, He B, Wang Y, Fu G, Chen J, An J, Xiu J, Guo X, Li Y, Cheng X, Li P, Chen Y, Zhou S, Sun Y, Yu B, Pan X, Han Y. One-Year Outcomes of Novel Transcatheter Edge-to-Edge Mitral Repair System in Patients With Functional Mitral Regurgitation. Catheter Cardiovasc Interv. 2025 Dec;106(7):3574-3582. doi: 10.1002/ccd.70230. Epub 2025 Oct 6.

    PubMed 41054211

Questions about this trial

What is this clinical trial studying?

A study testing SQ-Kyrin Transcatheter Mitral Valve Repair System in people with Functional Mitral 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 10 inclusion and 25 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 14 Aug 2023. 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?

Rate of all-cause death and hospitalization for heart failure (time frame: 12 months). 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 NCT05988450, which also lists 1 linked publication.

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 14 Aug 2023.

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