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

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

Overview

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.

Interventions

• Device SQ-Kyrin Transcatheter Mitral Valve Repair System
  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.

Primary outcome measures

• Number of patients with composite measures- All-cause death and recurrent hospitalizations due to heart failure [Time frame: 12 months]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.
• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Spain · 1 center

• Hospital Clínico Universitario de Valladolid — Valladolid

Identifiers

NCT: NCT06823700 · MVRP01-001C

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗