Degenerative Mitral Valve DiseaseNCT06021509
Clinical Study of NovoClasp for Treating Moderate to Severe and Severe Degenerative Mitral Regurgitation
A study testing NovoClasp® transcatheter mitral valve clip and steerable guide catheter in people with Degenerative Mitral Valve Disease, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease
- What is being tested?
- NovoClasp® transcatheter mitral valve clip and steerable guide catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2022to 25 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read the 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..
- Conditions
- Degenerative Mitral Valve Disease
- Being tested
- NovoClasp® transcatheter mitral valve clip and steerable guide catheter
- Keywords
- transcatheter edge-to-edge repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoClasp® transcatheter mitral valve clip and steerable guide catheterDevice
Also called transcatheter edge-to-edge repair for mitral valve
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.
| Study group | Role | What they receive |
|---|---|---|
| NovoClasp system | Experimental | Not described Receives: Device: NovoClasp® transcatheter mitral valve clip and steerable guide catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: through study completiong, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start15 May 2022
- Primary completion25 Jun 2024 (estimated)
- Study completion25 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Mitral Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021509
- Sponsor's protocol ID
- YM-2022-001
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06021509
- Acronym / sponsor ID
- YM-2022-001
- Conditions
- Degenerative Mitral Valve Disease
- Keywords
- transcatheter edge-to-edge repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Enlight Medical Technologies (Shanghai) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 May 2022 (actual)
- Primary completion
- 25 Jun 2024 (estimated)
- Study completion
- 25 Jun 2028 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NovoClasp system | Experimental | Device: NovoClasp® transcatheter mitral valve clip and steerable guide catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (22 listed)
- 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:
- History of cerebrovascular accident within the past 1 month.
- Acute deep vein thrombosis or acute pulmonary embolism history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NovoClasp® transcatheter mitral valve clip and steerable guide catheterAlso: transcatheter edge-to-edge repair for mitral valveThe 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. | Device | NovoClasp system |
Primary outcome
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).
4 secondary outcomes
Procedural success rate
Time frame: immediately after procedure
Procedural success rate
Time frame: During the perioperative period
Rate of Treatment success
Time frame: 30 days, 180 days
Changes in New York Heart Association (NYHA) Functional Classification
Time frame: through study completiong, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovoClasp® transcatheter mitral valve clip and steerable guide catheter in people with Degenerative Mitral Valve Disease, run by Enlight Medical Technologies (Shanghai) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effectiveness rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.