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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Valveclip® Transcatheter mitral valve repair
DeviceTranscatheter mitral valve repair system
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of product
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR\>2+ at 12 months).
Time frame
12 monthsSecondary outcomes
1
Efficacy of product
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR\>2+ at 30 days, 180 days, 2 to 5 years).
Time frame
30 days, 180 days, 2 to 5 years2
Rate of Cardiovascular related mortality
Cardiovascular related mortality after Transcatheter Mitral Valve Repairment
Time frame
30 days, 180 days, 1 year, 2 to 5 years3
Rate of Severe adverse events
Severe adverse events after Transcatheter Mitral Valve Repairment (including death, stroke, myocardial infarction, reoperation, instrumental non-selective cardiovascular surgery, renal failure, and adverse events related to transfemoral vein septal approach surgery, etc.）
Time frame
30 days, 180 days, 1 year, 2 to 5 years4
Quality of life Improvement
The 12-Item Short-Form Health Survey(SF-12)
Time frame
30 days, 180 days, 1 year, 2 to 5 yearsOther outcomes
1
Technical success
Technical success after Transcatheter Mitral Valve Repairment
Time frame
immediate post-surgical2
Device success
Device success after Transcatheter Mitral Valve Repairment
Time frame
30 days、180 days、1 year3
Procedural success
Procedural success after Transcatheter Mitral Valve Repairment
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov