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

Primary Purpose

Functional Mitral Regurgitation

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SQ-Kyrin Transcatheter Mitral Valve Repair System
Sponsored by
Shanghai Shenqi Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Mitral Regurgitation focused on measuring Functional Mitral Regurgitation, Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Northern Theater Command, PLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SQ-Kyrin TMVr System

Arm Description

Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.

Outcomes

Primary Outcome Measures

Rate of all-cause death and hospitalization for heart failure
Freefrom of all-cause death and hospitalization for heart failure

Secondary Outcome Measures

Technical success rate
No surgical death Delivery system for successful delivery and retrieval of devices Successful devices release and accurate positioning No need for any emergency surgery related to the device or surgical approach
Device success rate
Successfully implanted valve clip Transthoracic echocardiographic assessment showing MR ≤2+
Surgical success rate
Device success 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.
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;
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;
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;
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);
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;
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;

Full Information

First Posted
August 4, 2023
Last Updated
August 4, 2023
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05988450
Brief Title
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Shenqi Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Mitral Regurgitation
Keywords
Functional Mitral Regurgitation, Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SQ-Kyrin TMVr System
Arm Type
Experimental
Arm Description
Transcatheter edge-to-edge mitral valve repair using SQ-Kyrin TMVr System.
Intervention Type
Device
Intervention Name(s)
SQ-Kyrin Transcatheter Mitral Valve Repair System
Intervention Description
Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.
Primary Outcome Measure Information:
Title
Rate of all-cause death and hospitalization for heart failure
Description
Freefrom of all-cause death and hospitalization for heart failure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Technical success rate
Description
No surgical death Delivery system for successful delivery and retrieval of devices Successful devices release and accurate positioning No need for any emergency surgery related to the device or surgical approach
Time Frame
Immediate postoperative
Title
Device success rate
Description
Successfully implanted valve clip Transthoracic echocardiographic assessment showing MR ≤2+
Time Frame
30 days after surgery
Title
Surgical success rate
Description
Device success 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.
Time Frame
30 days after surgery
Title
Rate of MR 2+ or less than 2+ at 30 days, 6 months, and 12 months after surgery;
Description
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
Title
Rate of hospitalization for heart failure at 30 days, 6 months, and 12 months after surgery;
Description
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
Title
The rate of NYHA heart function class I or II at 30 days, 6 months, and 12 months after surgery;
Description
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
Title
Improvement in quality of life from baseline at 12 months after surgery (as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score);
Description
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
Title
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
Description
Improvement in 6-minute walk distance from baseline at 12 months after surgery;
Time Frame
12 months after surgery
Title
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
Description
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline at 12 months after surgery;
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, MD, Ph.D
Organizational Affiliation
General Hospital of Northern Theater Command, PLA
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Northern Theater Command, PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
123005
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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