SQ-Kyrin Transcatheter Mitral Valve Repair System Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);

• Patients with high or prohibitive risk for conventional open thoracic surgery as defined by STS risk scoring result; subjects who are judged as not tolerating mitral valve surgery due to STS procedural mortality risk ≥ 8% for mitral valve replacement or presence of any of the following risk factors:

‣ Porcelain aorta or active ascending aortic atheroma

⁃ Prior radiation therapy to mediastinum

⁃ History of mediastinitis

⁃ Left ventricular ejection fraction (LVEF) \< 40%

⁃ Presence of unobstructed coronary artery bypass graft

⁃ History of 2 or more cardiothoracic surgeries

⁃ Liver cirrhosis

⁃ Other surgical risk factors

• Degenerated MR patients, or functional MR patients who have received guideline-directed medical therapy (GDMT therapy)

• Age ≥ 18 years, male or female;

• Patients who are at extremely high risk or not suitable for conventional mitral valve surgery, as assessed by a multidisciplinary heart team (including at least one cardiac surgeon and one cardiologist);

• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the SQ-Kyrin device;

• Patients who can understand the objectives of the trial, volunteer to participate in the study, sign the informed consent form, and are willing to receive related examinations and clinical follow-up.

Locations
Other Locations
China
General Hospital of Northern Theater Command, PLA
RECRUITING
Shenyang
Contact Information
Primary
Grace Gu
guchaojun@sqmedical.com
13636491192
Time Frame
Start Date: 2021-04-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 20
Treatments
Experimental: SQ-Kyrin TMVr Feasibility Study
Experimental group is allocated to use the transcatheter edge-to-edge valve repair system of Shanghai Shenqi Medical Technology Co., Ltd.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Shenqi Medical Technology Co., Ltd

This content was sourced from clinicaltrials.gov