Functional Mitral RegurgitationNCT06823700
Safety and Effectiveness Study of SQ-Kyrin System for Functional Mitral Regurgitation in EU
A study testing SQ-Kyrin Transcatheter Mitral Valve Repair System in people with Functional Mitral Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in Spain.
Trial summary
The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 17 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participant who has provided written informed consent for the investigation.
- Age ≥18 years.
- Patients diagnosed with FMR.
- MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
- LVEF ≥20% to ≤60%.
- Symptom status: NYHA functional class II to IV despite a stable maximally tolerated GDMT regimen as per guidelines.
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- According to the judgment of local cardiology team, subjects have undergone adequate treatment for at least 30 days (preferably 90 days) based on the criteria recommended in the heart failure guidelines.
- Subject fulfils FMR anatomy selection criteria.
- According to the judgment of the local Cardiovascular medical-surgery team, subjects who have high or prohibitive risk for open heart surgery.
- 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.
- No obvious calcification of main grasp mitral valve leaflets.
- Patient anatomy allows atrial septum approach.
Who cannot join
- Life expectancy <1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
- Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
- UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
- Fixed pulmonary artery systolic pressure >70 mm Hg.
- Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
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- Mitral valve anatomy which may preclude proper device treatment.
- Mitral valve area < 4.0 cm2 (if new device therapy may further decrease the mitral orifice area).
- Any prior mitral valve surgery or transcatheter mitral valve procedure.
- Stroke or transient ischemic event within 30 days before enrolment.
- Modified Rankin ≥ Scale 4 disability.
- Severe symptomatic carotid stenosis (>70% by ultrasound).
- Need for emergent or urgent intervention for any reason or any planned cardiac intervention within the next 12 months.
- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month before enrolment.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Any percutaneous cardiovascular intervention, cardiovascular intervention, or carotid intervention within 30 days
- Tricuspid valve disease requiring intervention or severe or more tricuspid regurgitation.
- Aortic valve disease requiring intervention or any concomitant treatment.
- Need for any cardiovascular intervention (other than for MV disease).
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Active infections requiring current antibiotic therapy.
- Subjects in whom transoesophageal echocardiography is contraindicated or high risk.
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits.
- Patient unable or unwilling to provide written, informed consent before study enrolment.
- Pregnant woman or woman planning to become pregnant.
- Patients with severe liver, renal or pulmonary disease, which in investigator opinion may have an impact on patient safety.
- Clinically significant lab abnormalities which in investigator opinion may have an impact on patient safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47003
Ignacio J Amat-Santos, MD, Ph.D
About this study
Official title: A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation
The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
Read the detailed description
The primary objective is to verify the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. In the treatment of patients with moderate-severe (3 +) or severe (4 +) FMR whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- SQ-Kyrin Transcatheter Mitral Valve Repair System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQ-Kyrin Transcatheter Mitral Valve Repair SystemDevice
To percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping.
| Study group | Role | What they receive |
|---|---|---|
| SQ-Kyrin TMVr System | Experimental | Not described Receives: Device: SQ-Kyrin Transcatheter Mitral Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure
A composite of all-cause death and recurrent hospitalizations due to heart failure
Measured: 12 months
Secondary outcomes (13)
Technical success rate
Defined by the following four conditions:
- No procedural mortality. 2. Successful delivery, implant, retrieval of the delivery system. 3. Successful devices release. 4. No need for any emergency surgery related to the device or surgical approach.
Measured: immediately after intervention
Device success rate
Defined by the following three conditions:
- Technical success maintained at day 30. 2. Transthoracic echocardiographic assessment showing MR ≤2+ without significant mitral stenosis. 3. No structural or functional failure of the device.
Measured: 30 days
Procedural success rate
Defined by following two conditions:
- Device success. 2. No major adverse events occurred.
Measured: 30 days
The rate of New York Heart Association (NYHA) heart function class I or II
Measured: On the day of discharge, 30 days, 6 months, and 12 months
Improvement in quality of life from baseline
Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score, scale from 0 - 100, and higher scores mean a better outcome.
Measured: 12 months
Rate of MR 2+ or less than 2+
Mitral regurgitation severity grade 2+ or less than 2+
Measured: 30 days, 6 months, and 12 months
Change from baseline to discharge in MR severity assessed by echocardiography.
Measured: On the day of discharge
Rate of hospitalization for heart failure
Measured: 30 days, 6 months, and 12 months
Improvement by ≥ 50m in 6-minute walk distance from baseline
Measured: 12 months
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline
Measured: 12 months
Incidence of all-cause mortality
Measured: 30 days, 6 months, and 12 months
Cardiovascular-related mortality
Measured: 30 days, 6 months, and 12 months
Incidence of major adverse events
The major adverse event refers to the composite endpoint of death, stroke, myocardial infarction, and cardiovascular surgery due to device- or interventional-related adverse events that occurred since successful transfemoral vein puncture and establishment of atrial septal pathway.
Measured: 30 days and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start17 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional 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
- Model description
- Device: SQ-Kyrin Transcatheter Mitral Valve Repair System
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ignacio J Amat-Santos, MD, Ph.D, Principal investigator, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823700
- Sponsor's protocol ID
- MVRP01-001C
- Status last verified
- Feb 2025
- First submitted
- 30 May 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm Study to Evaluate the Safety and Effectiveness of Shenqi Transcatheter Mitral Valve Clips Delivery System and Steerable Guide Catheters in Patients with Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT06823700
- Acronym / sponsor ID
- MVRP01-001C
- Conditions
- Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai Shenqi Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
The investigation objective of this study is to evaluate the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in the population of FMR patients and the accessories devices when used in conjunction with the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter.
Detailed description
The primary objective is to verify the safety and effectiveness of the Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. In the treatment of patients with moderate-severe (3 +) or severe (4 +) FMR whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: SQ-Kyrin Transcatheter Mitral Valve Repair System
| Arm | Type | Receives |
|---|---|---|
| SQ-Kyrin TMVr System | Experimental | Device: SQ-Kyrin Transcatheter Mitral Valve Repair System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant who has provided written informed consent for the investigation.
- Age ≥18 years.
- Patients diagnosed with FMR.
- MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE).
- LVEF ≥20% to ≤60%.
Key exclusion criteria (28 listed)
- Life expectancy <1 year due to non-cardiac conditions or heart failure deemed suitable for palliative treatment.
- Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support.
- UNOS status 1 heart transplantation or prior orthotopic heart transplantation.
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
- Fixed pulmonary artery systolic pressure >70 mm Hg.
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 Mitral Valve Repair SystemTo percutaneously repair the mitral valve via the femoral vein and atrial septum, offering a treatment for symptomatic functional mitral regurgitation through edge-to-edge valve clipping. | Device | SQ-Kyrin TMVr System |
Primary outcome
Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure
Time frame: 12 months
A composite of all-cause death and recurrent hospitalizations due to heart failure
13 secondary outcomes
Technical success rate
Time frame: immediately after intervention
Device success rate
Time frame: 30 days
Procedural success rate
Time frame: 30 days
The rate of New York Heart Association (NYHA) heart function class I or II
Time frame: On the day of discharge, 30 days, 6 months, and 12 months
Improvement in quality of life from baseline
Time frame: 12 months
Rate of MR 2+ or less than 2+
Time frame: 30 days, 6 months, and 12 months
Change from baseline to discharge in MR severity assessed by echocardiography.
Time frame: On the day of discharge
Rate of hospitalization for heart failure
Time frame: 30 days, 6 months, and 12 months
Improvement by ≥ 50m in 6-minute walk distance from baseline
Time frame: 12 months
Improvement in left ventricular end-diastolic volume (LVEDV) from baseline
Time frame: 12 months
Incidence of all-cause mortality
Time frame: 30 days, 6 months, and 12 months
Cardiovascular-related mortality
Time frame: 30 days, 6 months, and 12 months
Incidence of major adverse events
Time frame: 30 days and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
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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.
Ignacio J Amat-Santos, MD, Ph.D principal investigator
Hospital Clínico Universitario de Valladolid
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 Mitral Valve Repair System in people with Functional Mitral Regurgitation, run by Shanghai Shenqi Medical Technology Co., Ltd at 1 site in Spain.
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 28 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Director (+86 13636491192, chaojun.gu@sqmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure (time frame: 12 months). 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 12 Feb 2025.