Back to resultsSQ-Kyrin TMVr FIM Study
Primary Purpose
Mitral Regurgitation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Regurgitation focused on measuring Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);
Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:
- Porcelain aorta or active ascending aortic atheroma
- Prior radiation therapy to mediastinum
- History of mediastinitis
- Left ventricular ejection fraction (LVEF) < 40%
- Presence of unobstructed coronary artery bypass graft
- History of 2 or more cardiothoracic surgeries
- Liver cirrhosis
- Other surgical risk factors
- Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)
- Age ≥ 18 years, male or female;
- Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);
- Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;
- Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.
Exclusion Criteria:
- History of cardiac and mitral valve surgeries;
- Infective endocarditis or evidence of active infection;
- Mitral valve stenosis;
- Severe uncontrolled coronary artery disease;
- Pulmonary artery hypertension (systolic pulmonary artery pressure > 70 mmHg);
- Severe right cardiac insufficiency;
- LVEF < 30%;
- Cardiac function of NYHA Class IV;
- Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support;
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
- Chronic dialysis;
- Definite coagulation disorder and severe coagulation system diseases;
- Clear contraindications for use of anticoagulants;
- Cerebral stroke or transient ischemic attack in the past 30 days;
- Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography;
- Other valve diseases that requiring surgery or intervention;
- Severe macrovascular disease requiring surgical treatment;
- Treatment-naive carotid artery stenosis > 70%;
- Imaging evidence of inappropriate cardiac and valve anatomy;
- Known hypersensitivity to contrast media, and nickel-titanium memory alloy products;
- Severe nervous system disorder compromising the cognitive ability;
- Life expectancy < 12 months;
- Severe thorax deformity;
- Pregnant and lactating women.
Sites / Locations
- General Hospital of Northern Theater Command, PLARecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SQ-Kyrin TMVr Feasibility Study
Arm Description
Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd.
Outcomes
Primary Outcome Measures
Incidence of acute procedural success
Must meet all the four items：1）no procedural mortality; 2）success in delivery and retrieval of the device delivery system; 3）successful deployment and accurate positioning of the device; 4）no emergency surgery or reintervention related to the device or surgical approach
Secondary Outcome Measures
All-cause mortality
Death from any cause
Incidence of serious adverse event(SAE)
If the adverse event meets any of the criteria below, it is regarded as a serious adverse event (SAE): 1) results in death; 2) is life threatening, results in illness or injury; 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect, fetal death, fetal distress; 6) results in medical or surgical intervention to prevent permanent impairment to body structure or a body function; 7) an important medical event that may not result in death, be life-threatening, or require hospitalization but may be considered serious when, based upon appropriate medical judgment, may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed in this definition.
Device success rate
Definition of device success（must meet all the four items） ：1) No procedural mortality or stroke；2) Proper deployment and positioning of the device；3) No emergency surgery or reintervention related to the device or surgical approach；4) The implanted mitral valve repair system achieves the following safety and effectiveness indicators:
No evidence of structural or functional abnormality
No device-related technical failure or complication
Significant functional improvement after valve repair, without significant stenosis (post-op EOA ≥ 1.5 cm2 and transvalvular pressure gradient < 5 mmHg/valve regurgitation ≤ Grade 2+/no device-related hemolysis)
Procedural success rate
Definition of procedural success（must meet the two items）：1) Device success；2) Absence of the following severe complications: death; stroke; life-threatening hemorrhage; severe vascular complications; secondary severe organic heart diseases (e.g.: aortic dissection, left atrium/auricle rupture, left ventricular outflow tract obstruction, etc.); Grade II-III and above renal insufficiency; myocardial infarction or coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); severe hypotension, heart failure, respiratory failure requiring use of high-dose vasoactive medications/mechanical acids; any valve-related dysfunctions, including repair device detachment (single or two valve leaflets)/embolism/device-related autologous mitral valve damage/other conditions requiring second intervention.
Full Information
NCT ID
NCT05040074
First Posted
August 12, 2021
Last Updated
September 1, 2021
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05040074
Brief Title
SQ-Kyrin TMVr FIM Study
Official Title
SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2026 (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
5. Study Description
Brief Summary
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
Detailed Description
This is a prospective, multicenter, single-arm observation, feasibility clinical study that plans to enroll a total of not less than 10 and not more than 30 patients, adopts the post-op immediate technical success rate as the primary endpoint, and uses the all-cause mortality at 30 days post-op, incidence of serious adverse event at 30 days post-op, device success rate at 30 days post-op, and procedural success rate at 30 days post-op as secondary endpoints to evaluate the effectiveness, safety, and feasibility of the Transcatheter Edge-to-Edge Valve Repair System of Shanghai Shenqi Medical Technology Co., Ltd. in clinical use and preliminarily evaluate the product's performance. A phasic study report (for phasic data summary and analysis) will be issued after completion of the 30-day postoperative follow-up to evaluate the effectiveness, safety, and feasibility of the device and apply for clinical studies before official registration and marketing. In the meantime, patients enrolled will continue to be followed up for 6 months and 1-5 years post-op to evaluate the long-term effect of the mitral valve repair system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation
Keywords
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
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SQ-Kyrin TMVr Feasibility Study
Arm Type
Experimental
Arm Description
Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd.
Intervention Type
Device
Intervention Name(s)
SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
Intervention Description
Transesophageal echocardiography-guided, implantable mitral valve clip repair system
Primary Outcome Measure Information:
Title
Incidence of acute procedural success
Description
Must meet all the four items：1）no procedural mortality; 2）success in delivery and retrieval of the device delivery system; 3）successful deployment and accurate positioning of the device; 4）no emergency surgery or reintervention related to the device or surgical approach
Time Frame
Immediate postoperative
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Death from any cause
Time Frame
1 month
Title
Incidence of serious adverse event(SAE)
Description
If the adverse event meets any of the criteria below, it is regarded as a serious adverse event (SAE): 1) results in death; 2) is life threatening, results in illness or injury; 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect, fetal death, fetal distress; 6) results in medical or surgical intervention to prevent permanent impairment to body structure or a body function; 7) an important medical event that may not result in death, be life-threatening, or require hospitalization but may be considered serious when, based upon appropriate medical judgment, may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed in this definition.
Time Frame
1 month
Title
Device success rate
Description
Definition of device success（must meet all the four items） ：1) No procedural mortality or stroke；2) Proper deployment and positioning of the device；3) No emergency surgery or reintervention related to the device or surgical approach；4) The implanted mitral valve repair system achieves the following safety and effectiveness indicators:
No evidence of structural or functional abnormality
No device-related technical failure or complication
Significant functional improvement after valve repair, without significant stenosis (post-op EOA ≥ 1.5 cm2 and transvalvular pressure gradient < 5 mmHg/valve regurgitation ≤ Grade 2+/no device-related hemolysis)
Time Frame
1 month
Title
Procedural success rate
Description
Definition of procedural success（must meet the two items）：1) Device success；2) Absence of the following severe complications: death; stroke; life-threatening hemorrhage; severe vascular complications; secondary severe organic heart diseases (e.g.: aortic dissection, left atrium/auricle rupture, left ventricular outflow tract obstruction, etc.); Grade II-III and above renal insufficiency; myocardial infarction or coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); severe hypotension, heart failure, respiratory failure requiring use of high-dose vasoactive medications/mechanical acids; any valve-related dysfunctions, including repair device detachment (single or two valve leaflets)/embolism/device-related autologous mitral valve damage/other conditions requiring second intervention.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);
Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:
Porcelain aorta or active ascending aortic atheroma
Prior radiation therapy to mediastinum
History of mediastinitis
Left ventricular ejection fraction (LVEF) < 40%
Presence of unobstructed coronary artery bypass graft
History of 2 or more cardiothoracic surgeries
Liver cirrhosis
Other surgical risk factors
Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)
Age ≥ 18 years, male or female;
Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);
Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;
Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.
Exclusion Criteria:
History of cardiac and mitral valve surgeries;
Infective endocarditis or evidence of active infection;
Mitral valve stenosis;
Severe uncontrolled coronary artery disease;
Pulmonary artery hypertension (systolic pulmonary artery pressure > 70 mmHg);
Severe right cardiac insufficiency;
LVEF < 30%;
Cardiac function of NYHA Class IV;
Patient is extremely week to tolerate surgery under general anesthesia, or in a shock state indicating circulatory support;
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or constrictive pericarditis;
Chronic dialysis;
Definite coagulation disorder and severe coagulation system diseases;
Clear contraindications for use of anticoagulants;
Cerebral stroke or transient ischemic attack in the past 30 days;
Any cardiac mass, left ventricular or atrial thrombosis identified by echocardiography;
Other valve diseases that requiring surgery or intervention;
Severe macrovascular disease requiring surgical treatment;
Treatment-naive carotid artery stenosis > 70%;
Imaging evidence of inappropriate cardiac and valve anatomy;
Known hypersensitivity to contrast media, and nickel-titanium memory alloy products;
Severe nervous system disorder compromising the cognitive ability;
Life expectancy < 12 months;
Severe thorax deformity;
Pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Gu
Phone
13636491192
Email
guchaojun@sqmedical.com
Facility Information:
Facility Name
General Hospital of Northern Theater Command, PLA
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
123005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaling Han, PhD
12. IPD Sharing Statement
Learn more about this trial
SQ-Kyrin TMVr FIM Study
We'll reach out to this number within 24 hrs