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

Recruiting N/A Interventional Study
Functional Mitral Regurgitation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
34 (estimated)
Sponsor
Shanghai Shenqi Medical Technology Co., Ltd · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Participant who has provided written informed consent for the investigation. 2. Age ≥18 years. 3. Patients diagnosed with FMR. 4. MR severity is (functional) ≥3+ as determined by transthoracic echocardiography (TTE). 5. LVEF ≥20% to ≤60%. 6. Symptom status: NYHA functional cl…
Contacts

Clinical Director

+86 13636491192

chaojun.gu@sqmedical.com

CONTACT