Clinical trial NCT06021509: Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Mitral Valve Disease
Keywords: transcatheter edge-to-edge repair
Lead sponsor: Enlight Medical Technologies (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-01
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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..

Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following criteria to be eligible for this study.

1. Age 18 years.
2. 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.
3. Confirmation by echocardiography of moderate to severe (3+) or severe (4+) degenerative mitral regurgitation.
4. Echocardiography showing left ventricular ejection fraction 30%, left ventricular end-systolic diameter (LVESD) 60mm, and pulmonary artery systolic pressure (PASP) 70 mmHg.
5. NYHA functional classification II-IV.
6. Presence of a primary regurgitant jet; if a secondary regurgitant jet is present, it should be clinically insignificant based on investigator assessment.
7. Evaluated by a multidisciplinary team as suitable for the investigational procedure using the study device.
8. 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.

1. History of prior mitral valve surgery or heart transplant.
2. Severe organ dysfunction that may affect study evaluation, including but not limited to:

   1. Right heart failure or biventricular heart failure.
   2. Severe restrictive or obstructive lung disease (COPD) requiring continuous oxygen therapy or oral steroid treatment.
   3. Severe renal insufficiency requiring or likely to require continuous renal replacement therapy (CRRT) or dialysis postoperatively.
   4. Severe carotid artery stenosis confirmed by imaging to be \>70%.
3. History of cerebrovascular accident within the past 1 month.
4. Acute deep vein thrombosis or acute pulmonary embolism history.
5. Any known active infection.
6. Active infective endocarditis (eligible 6 weeks after standard antimicrobial treatment), rheumatic heart valve disease, or radiation-induced valve disease.
7. Cardiac or major vascular surgical or interventional procedure within 30 days (coronary angiography is allowed).
8. Coexisting moderate or greater valvular disease (aortic valve, tricuspid valve, pulmonary valve stenosis or regurgitation).
9. Known other cardiac or major vascular diseases requiring surgical or interventional intervention, including but not limited to coronary artery disease, myocardial disease, aortic disease (except for coronary angiography).
10. 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:

    1. Unsuitable for leaflet capture due to severe calcification or cleft.
    2. Lack of primary and secondary chordal support in the capture area.
    3. Leaflet free edge length \< 0.8 cm.
11. Known conditions that preclude study procedure (including but not limited to allergies to device components, coagulation disorders, life expectancy \< 1 year).
12. Pregnant or breastfeeding women or those planning pregnancy during the trial period.
13. Intending or currently participating in another interventional clinical trial.
14. Other conditions deemed inappropriate for participation in this study by the investigator.

Primary outcomes:
measure: Treatment effectiveness rate
timeFrame: 1 year
Secondary outcomes:
measure: Procedural success rate
timeFrame: immediately after procedure
measure: Procedural success rate
timeFrame: During the perioperative period
measure: Rate of Treatment success
timeFrame: 30 days, 180 days
measure: Changes in New York Heart Association (NYHA) Functional Classification
timeFrame: through study completiong, an average of 1 year.
Other outcomes:
measure: All cause mortality
timeFrame: through study completion, an average of 1 year
measure: Device/Procedure-related mortality
timeFrame: through study completion, an average of 1 year
measure: Major adverse events
timeFrame: through study completion, an average of 1 year
measure: Serious adverse events
timeFrame: through study completion, an average of 1 year
measure: Number of participants with device-related adverse events
timeFrame: through study completion, an average of 1 year
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: