NCT05988450

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

A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Clip Delivery System and Steerable Guide Catheter in Patients With Moderate-severe or Severe Functional MR (FMR)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Shanghai Shenqi Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd. in patients with moderate-severe (3 +) or severe (4 +) functional MR (functional MR) who still have symptoms after full treatment.

Detailed description

This study is a prospective, multi-center, single arm clinical study designed to evaluate the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter in patients with moderate-severe (3 +) or severe (4 +) functional MR (Functional MR) who still have symptoms after adequate treatment. This trial will be conducted at 41 sites in China and is planned to include a total of 118 subjects. All subjects received the trial device for transcatheter mitral valve clip delivery system and steerable guide catheter, and were followed up at 30 days, 6 months, and 12 months after surgery. The composite endpoint of all-cause death and hospitalization for heart failure was assessed at 12 months after surgery. After the 12th month follow-up, the statistical analysis, clinical summary and application for product registration were carried out.

Conditions

• Functional Mitral Regurgitation

Interventions

Type	Name	Description
DEVICE	SQ-Kyrin Transcatheter Mitral Valve Repair System	Transcatheter mitral valve clip placement to repair the valve and correct regurgitation.

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-12-01
• Completion: 2027-12-01
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: China