A Prospective, Multicenter, Single-arm Clinical Study of NovoClasp Transcatheter Mitral Valve Clip and Steerable Guide Catheter for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation (DMR)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Degenerative Mitral Valve Disease
- Sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Treatment effectiveness rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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).
Detailed Description
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..
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following criteria to be eligible for this study.
- •Age 18 years.
- •Willingness to comply with the protocol requirements and data collection procedures, ability to understand the purpose of the trial, voluntary participation, and signing of informed consent by the subject or legal guardian.
- •Confirmation by echocardiography of moderate to severe (3+) or severe (4+) degenerative mitral regurgitation.
- •Echocardiography showing left ventricular ejection fraction 30%, left ventricular end-systolic diameter (LVESD) 60mm, and pulmonary artery systolic pressure (PASP) 70 mmHg.
- •NYHA functional classification II-IV.
- •Presence of a primary regurgitant jet; if a secondary regurgitant jet is present, it should be clinically insignificant based on investigator assessment.
- •Evaluated by a multidisciplinary team as suitable for the investigational procedure using the study device.
- •Society of Thoracic Surgeons (STS) score 4 or evaluated as high surgical risk for mitral valve repair by two cardiac surgeons.
Exclusion Criteria
- •Subjects meeting any of the following criteria are not eligible for this study.
- •History of prior mitral valve surgery or heart transplant.
- •Severe organ dysfunction that may affect study evaluation, including but not limited to:
- •Right heart failure or biventricular heart failure.
- •Severe restrictive or obstructive lung disease (COPD) requiring continuous oxygen therapy or oral steroid treatment.
- •Severe renal insufficiency requiring or likely to require continuous renal replacement therapy (CRRT) or dialysis postoperatively.
- •Severe carotid artery stenosis confirmed by imaging to be \>70%.
- •History of cerebrovascular accident within the past 1 month.
- •Acute deep vein thrombosis or acute pulmonary embolism history.
- •Any known active infection.
Outcomes
Primary Outcomes
Treatment effectiveness rate
Time Frame: 1 year
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).
Secondary Outcomes
- Rate of Treatment success(30 days, 180 days)
- Procedural success rate(During the perioperative period)
- Changes in New York Heart Association (NYHA) Functional Classification(through study completiong, an average of 1 year.)