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

August 4, 2023 updated by: Shanghai Shenqi Medical Technology Co., Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 123005
        • General Hospital of Northern Theater Command, PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Severe functional MR (FMR) ≥3+ as determined by transthoracic echocardiography (TTE);
  2. 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).
  3. Age ≥ 18 years old, regardless of gender;
  4. Cardiac function classification NYHA class II, III or ambulatory IV a;
  5. 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.
  6. 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.
  7. Left ventricular end-systolic diameter (LVESD)≤70mm
  8. The MR beam mainly originates from the A2/P2 area
  9. Mitral valve coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>10mm
  10. Mitral valve effective orifice area (EOA) ≥ 4.0cm2

Exclusion Criteria:

  1. History of mitral valve surgery;
  2. Patients with infective endocarditis or suggestive of active infection;
  3. Complicated with severe untreated coronary artery disease;
  4. Patients with pulmonary hypertension (pulmonary systolic blood pressure>70mmHg);
  5. patients with transthoracic echocardiographic evidence of moderate-severe to severe right ventricular dysfunction;
  6. Left heart ejection fraction <20%;
  7. Patients who are extremely frail and cannot tolerate general anesthesia surgery or is in the state of shock requiring circulatory support;
  8. Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis;
  9. Severe renal insufficiency (eGFR ≤ 25 mL/min) or requiring chronic renal replacement therapy;
  10. Patients with definite coagulation disorders and severe coagulation system diseases;
  11. Patients with clear contraindications to the use of anticoagulants;
  12. Patients with stroke or transient cerebral ischemic attack within 30 days;
  13. Received cardiac pacemaker therapy or cardiac resynchronization therapy (CRT, CRT-D) or implanted cardioverter-defibrillator (ICD) implantation therapy within 30 days;
  14. Any intracardiac mass, left ventricular or atrial thrombus detected on transthoracic echocardiography;
  15. Severe tricuspid TR;
  16. Patients with other valve disease requiring surgery or interventional therapy;
  17. Patients with severe macrovascular disease requiring surgical treatment;
  18. Severe symptomatic carotid stenosis (>70% on ultrasonography) or carotid stenting within 30 days;
  19. Patients with inappropriate anatomical structures of the heart and valves indicated by imaging examinations;
  20. Known allergy to contrast agents and nickel-titanium memory alloy products;
  21. <Resting systolic blood pressure 90 mmHg or >160 mmHg;
  22. 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.;
  23. Patient life expectancy < 12 months;
  24. Patients with severe thoracic deformity;
  25. Women who are pregnant, breastfeeding, or planning to become pregnant within the next 12 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SQ-Kyrin TMVr System
Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.
Device: SQ-Kyrin Transcatheter Mitral Valve Repair System
Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of all-cause death and hospitalization for heart failure
Time Frame: 12 months
Freefrom of all-cause death and hospitalization for heart failure
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success rate
Time Frame: Immediate postoperative
  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
Immediate postoperative
Device success rate
Time Frame: 30 days after surgery
  1. Successfully implanted valve clip
  2. Transthoracic echocardiographic assessment showing MR ≤2+
30 days after surgery
Surgical success rate
Time Frame: 30 days after surgery
  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.
30 days after surgery
Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
Time Frame: 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;
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;
Time Frame: 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;
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;
Time Frame: 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;
30 days, 6 months, and 12 months after surgery
Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
Time Frame: 12 months after surgery
Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
12 months after surgery
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
Time Frame: 12 months after surgery
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
12 months after surgery
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
Time Frame: 12 months after surgery
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Shenqi Medical Technology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yaling Han, MD, Ph.D, General Hospital of Northern Theater Command, PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MVRP01-001A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings