- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988450
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
Active, not recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
125
Phase
- 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
-
-
Liaoning
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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%;
- 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.
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 |
Intervention / Treatment |
---|---|
Experimental: SQ-Kyrin TMVr System
Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.
|
Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.
|
What is the study measuring?
Primary Outcome Measures
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technical success rate
Time Frame: Immediate postoperative
|
|
Immediate postoperative
|
Device success rate
Time Frame: 30 days after surgery
|
|
30 days after surgery
|
Surgical success rate
Time Frame: 30 days after surgery
|
|
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.
Investigators
- 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)
March 7, 2022
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
August 4, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 4, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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