Mitral RegurgitationNCT05040074
SQ-Kyrin TMVr FIM Study
A study testing SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System in people with Mitral Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 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%
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command, PLA
Shenyang, Liaoning, 123005
Yaling Han, PhD
About this study
Official title: SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study
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.
Read the 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.
- Conditions
- Mitral Regurgitation
- Being tested
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
- Keywords
- 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 Edge-to-Edge Valve Repair SystemDevice
Transesophageal echocardiography-guided, implantable mitral valve clip repair system
| Study group | Role | What they receive |
|---|---|---|
| SQ-Kyrin TMVr Feasibility Study | Experimental | Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd. Receives: Device: SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate postoperative
Secondary outcomes (4)
All-cause mortality
Death from any cause
Measured: 1 month
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.
Measured: 1 month
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)
Measured: 1 month
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Apr 2021
- Primary completionOct 2022 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040074
- Sponsor's protocol ID
- VRP01-001
- Status last verified
- Aug 2021
- First submitted
- 12 Aug 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study
- ClinicalTrials.gov ID
- NCT05040074
- Acronym / sponsor ID
- VRP01-001
- Conditions
- Mitral Regurgitation
- Keywords
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SQ-Kyrin TMVr Feasibility Study | Experimental | Device: SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair SystemExperimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- 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);
Key exclusion criteria (24 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair SystemTransesophageal echocardiography-guided, implantable mitral valve clip repair system | Device | SQ-Kyrin TMVr Feasibility Study |
Primary outcome
Incidence of acute procedural success
Time frame: Immediate postoperative
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
4 secondary outcomes
All-cause mortality
Time frame: 1 month
Incidence of serious adverse event(SAE)
Time frame: 1 month
Device success rate
Time frame: 1 month
Procedural success rate
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System in people with 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 15 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 10 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Grace Gu (13636491192, guchaojun@sqmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of acute procedural success (time frame: Immediate postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2021.