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Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation

Primary Purpose

Degenerative Mitral Valve Disease

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NovoClasp® transcatheter mitral valve clip and steerable guide catheter
Sponsored by
Enlight Medical Technologies (Shanghai) Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Mitral Valve Disease focused on measuring transcatheter edge-to-edge repair

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Active infective endocarditis (eligible 6 weeks after standard antimicrobial treatment), rheumatic heart valve disease, or radiation-induced valve disease. Cardiac or major vascular surgical or interventional procedure within 30 days (coronary angiography is allowed). Coexisting moderate or greater valvular disease (aortic valve, tricuspid valve, pulmonary valve stenosis or regurgitation). 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). 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: Unsuitable for leaflet capture due to severe calcification or cleft. Lack of primary and secondary chordal support in the capture area. Leaflet free edge length < 0.8 cm. Known conditions that preclude study procedure (including but not limited to allergies to device components, coagulation disorders, life expectancy < 1 year). Pregnant or breastfeeding women or those planning pregnancy during the trial period. Intending or currently participating in another interventional clinical trial. Other conditions deemed inappropriate for participation in this study by the investigator.

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NovoClasp system

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
August 15, 2023
Last Updated
August 28, 2023
Sponsor
Enlight Medical Technologies (Shanghai) Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06021509
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
June 25, 2024 (Anticipated)
Study Completion Date
June 25, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enlight Medical Technologies (Shanghai) Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Mitral Valve Disease
Keywords
transcatheter edge-to-edge repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NovoClasp system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NovoClasp® transcatheter mitral valve clip and steerable guide catheter
Other Intervention Name(s)
transcatheter edge-to-edge repair for mitral valve
Intervention Description
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.
Primary Outcome Measure Information:
Title
Treatment effectiveness rate
Description
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
Secondary Outcome Measure Information:
Title
Procedural success rate
Description
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
Title
Procedural success rate
Description
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
Title
Rate of Treatment success
Description
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
Title
Changes in New York Heart Association (NYHA) Functional Classification
Description
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.
Other Pre-specified Outcome Measures:
Title
All cause mortality
Time Frame
through study completion, an average of 1 year
Title
Device/Procedure-related mortality
Time Frame
through study completion, an average of 1 year
Title
Major adverse events
Time Frame
through study completion, an average of 1 year
Title
Serious adverse events
Time Frame
through study completion, an average of 1 year
Title
Number of participants with device-related adverse events
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. Active infective endocarditis (eligible 6 weeks after standard antimicrobial treatment), rheumatic heart valve disease, or radiation-induced valve disease. Cardiac or major vascular surgical or interventional procedure within 30 days (coronary angiography is allowed). Coexisting moderate or greater valvular disease (aortic valve, tricuspid valve, pulmonary valve stenosis or regurgitation). 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). 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: Unsuitable for leaflet capture due to severe calcification or cleft. Lack of primary and secondary chordal support in the capture area. Leaflet free edge length < 0.8 cm. Known conditions that preclude study procedure (including but not limited to allergies to device components, coagulation disorders, life expectancy < 1 year). Pregnant or breastfeeding women or those planning pregnancy during the trial period. Intending or currently participating in another interventional clinical trial. Other conditions deemed inappropriate for participation in this study by the investigator.
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
Country
China

12. IPD Sharing Statement

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Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation

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