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

NCT06823700 | Recruiting DMC

• 1 other identifier: MVRP01-001C
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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 Steerable Guide Catheter.

Conditions

Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (13)

• Technical success rate

  immediately after intervention

• Device success rate

  30 days

• Procedural success rate

  30 days

• The rate of New York Heart Association (NYHA) heart function class I or II

  On the day of discharge, 30 days, 6 months, and 12 months

• Improvement in quality of life from baseline

  12 months

Study Arms (1)

SQ-Kyrin TMVr System

EXPERIMENTAL

Device: SQ-Kyrin Transcatheter Mitral Valve Repair System

Interventions

SQ-Kyrin Transcatheter Mitral Valve Repair System DEVICE

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.

SQ-Kyrin TMVr System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47003, Spain

RECRUITING

Study Officials

• Ignacio J Amat-Santos, MD, Ph.D

  Hospital Clínico Universitario de Valladolid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Director

CONTACT

+86 13636491192; chaojun.gu@sqmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device: SQ-Kyrin Transcatheter Mitral Valve Repair System

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: February 12, 2025
• Study Start: December 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)