An interventional study of NovoClasp® transcatheter mitral valve clip and steerable guide catheter in Degenerative Mitral Valve Disease, sponsored by Enlight Medical Technologies (Shanghai) Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Enlight Medical Technologies (Shanghai) Co., Ltd · Not applicable, Interventional, and Treatment
To validate the safety and efficacy of transcatheter edge-to-edge repair (TEER) using the NovoClasp® transcatheter mitral valve clip and steerable guide catheter in the treatment of moderate to severe and severe degenerative mitral regurgitation (DMR).
This trial is a prospective multi-center single-arm confirmatory study. A total of 102 subjects will be enrolled in multiple centers nationwide. Subjects who meet the trial requirements, fulfill the inclusion criteria, voluntarily participate in the study, and provide informed consent will undergo mitral edge-to-edge repair using the NovoClasp® transcatheter mitral valve clip system and steerable guide catheter for the treatment of moderate to severe or severe degenerative mitral regurgitation (DMR). Follow-up assessments will be conducted at discharge, as well as at 30 days, 90 days, 180 days, and 360 days postoperatively. The primary endpoint will be the treatment effectiveness rate at 360 days post-surgery. Secondary endpoint measures include treatment effectiveness at other time points, surgical success rate, all-cause mortality, device/procedure-related mortality, incidence of adverse events, and serious adverse event rates. The trial aims to comprehensively assess the safety and efficacy of the NovoClasp® transcatheter mitral valve clip and steerable guide catheter produced by Enlight Medical Technologies (Shanghai) Co., Ltd..
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's enrollment of 102 is above the median of 61 across 274 interventional studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →Enlight Medical Technologies (Shanghai) Co., Ltd is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects must meet all of the following criteria to be eligible for this study.
Exclusion Criteria:
Subjects meeting any of the following criteria are not eligible for this study.
Severe organ dysfunction that may affect study evaluation, including but not limited to:
Echocardiographic evidence of intracardiac mass, thrombus, vegetation, or mitral valve orifice area (MVOA) 4.0 cm2, or any condition unsuitable for the study device, including but not limited to:
Device: NovoClasp® transcatheter mitral valve clip and steerable guide catheter
The experimental device is a class III implanted valve device, which will be used to treat the mitral valve regurgitation via transcatheter edge-to-edge repair.
Also known as: transcatheter edge-to-edge repair for mitral valve
Treatment effectiveness rate
Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (\<=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).
Time frame: 1 year
Procedural success rate
Successful implantation of a single device as intended by the operator, successful retrieval of the delivery system, absence of device migration, dislodgment, embolization, related complications, or other unforeseen incidents.
Time frame: immediately after procedure
Procedural success rate
Defined as successful completion of the investigational procedure as intended by the operator (implantation of at least 1 study device) and reduction of mitral valve regurgitation to moderate or below (\<=2+), without open surgery, major adverse events during the perioperative period, or secondary interventions (interventional or surgical). Note: Major adverse events include cardiovascular-related deaths, stroke, myocardial infarction, need for renal replacement therapy, severe bleeding (hemoglobin decrease \>=3g/dL compared to baseline, or requiring \>=3 units of blood transfusion), or organ damage, failure, or death dur to blood loss.
Time frame: During the perioperative period
Rate of Treatment success
Treatment effectiveness is defined as the success of the procedure with the mitral valve regurgitation sustained at moderate or lower (\<=2+) after the surgery, without major adverse events or secondary interventions (interventional or surgical).
Time frame: 30 days, 180 days
Changes in New York Heart Association (NYHA) Functional Classification
The NYHA Classification provides nomenclature to describe an overall cardiac appraisal of the status of a patient with heart disease. Class I: Patients with cardiac disease but without resulting limitation of physical activity. Class II: patients with cardiac disease resulting in slight limitation of physical activity. Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Class IV: Patient with cardiac disease resulting in inability to carry on any physical activity without discomfor.
Time frame: through study completiong, an average of 1 year.
All cause mortality
Time frame: through study completion, an average of 1 year
Device/Procedure-related mortality
Time frame: through study completion, an average of 1 year
Major adverse events
Time frame: through study completion, an average of 1 year
Serious adverse events
Time frame: through study completion, an average of 1 year
Number of participants with device-related adverse events
Time frame: through study completion, an average of 1 year
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Enlight Medical Technologies (Shanghai) Co., Ltd