NCT06823700

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-17
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-12
• Last updated: 2025-02-12

Locations

1 site across 1 country: Spain