Valveclip® Transcatheter Mitral Valve Repair Study
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorShanghai NewMed Medical Co., Ltd.
About this trial
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
Eligibility criteria
Qualifiers
Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
Age≥70 years; or patients who are 60~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy;
The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards);
Disqualifiers
Previous cardiac mitral valve surgery;
Patients with Infective endocarditis or having an active infection;
Patients with mitral regurgitation caused by pure mitral stenosis;
Combined with untreated severe coronary artery disease
Trial design
Treatments tested in this trial
- Valveclip® Transcatheter mitral valve repair
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov