SQ-Kyrin TMVr FIM Study
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Shenqi Medical Technology Co., Ltd
About this trial
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 criteria
Qualifiers
Severe mitral valve regurgitation ≥ 3+ (moderate-to-severe mitral regurgitation disease);
Porcelain aorta or active ascending aortic atheroma
Prior radiation therapy to mediastinum
History of mediastinitis
Disqualifiers
History of cardiac and mitral valve surgeries;
Infective endocarditis or evidence of active infection;
Mitral valve stenosis;
Severe uncontrolled coronary artery disease;
Trial design
Treatments tested in this trial
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov