Degenerative Mitral Valve DiseaseNCT05417945
A Prospective, Multicenter Study to Evaluate the JensClip Transcatheter Valve Repair System
A study testing JensClip transcatheter valve repair system in people with Degenerative Mitral Valve Disease and Mitral Valve Regurgitation, run by Jenscare Scientific.
Trial summary
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease, Mitral Valve Regurgitation
- What is being tested?
- JensClip transcatheter valve repair system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years;
- Echocardiographically confirmed moderate-severe or severe degenerative mitral regurgitation (regurgitation degree MR ≥ 3+);
- NYHA Classification II-IV.
- LVEF ≥ 20%
- Patients considered at high surgical risk after evaluation by two or more cardiovascular specialists (American Association for Thoracic Surgery STS score: risk of death from mitral valve repair ≥ 6% or from mitral valve replacement ≥ 8% (high risk); or the presence of 2 or more indices of frailty (moderate to severe frailty); or the presence of 2 or more major organ insufficiencies that do not improve postoperatively; or a comprehensive cardiac team assessment that the patient has other combined diseases or factors that make him or her unsuitable for surgery)
- Anatomically suitable for mitral valve repair and assessed as suitable for use of this investigational device.
- Voluntarily participate and sign an informed consent form and be willing to accept relevant examinations and clinical follow-up.
Who cannot join
- Severe mitral valve calcification
- Previous implantation of a prosthetic mitral valvuloplasty ring or prosthetic mitral valve, or previous transcatheter mitral valve surgery
- Patients with active infective endocarditis
- Patients with mitral stenosis
- Any intracardiac mass, left ventricular or atrial thrombus detected by echocardiography
- Severe coronary stenosis without surgical or interventional treatment or an acute myocardial infarction within 90 days
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- Combined with tricuspid, aortic valve or severe macrovascular pathology requiring surgical or interventional treatment
- Severe pulmonary hypertension (pulmonary artery systolic pressure > 70 mmHg measured by ultrasound or right heart catheter, if measured at the same time the right heart catheter measurement shall prevail).
- Patients with severe right heart insufficiency
- Hemodynamic instability, defined as systolic blood pressure <90 mmHg in the absence of afterload-reducing drugs, cardiogenic shock, or use of intra-aortic balloon pump;
- Had a stroke/transient ischemic attack (TIA) within 30 days or severe carotid stenosis (> 70% stenosis on ultrasonography)
- Have undergone transcatheter cardiovascular intervention (PCI) within 30 days, or cardiovascular surgery within 180 days
- Have had a pacemaker or cardioverter-defibrillator (ICD) implanted, or have undergone cardiac resynchronization therapy (CRT, CRT-D) within 30 days
- Patients with clear coagulation disorders and severe coagulation disorders, or with clear contraindications to the anticoagulant drugs
- Known hypersensitivity to product composition
- Patients with severe neurological pathology affecting cognitive ability
- Patients with a life expectancy of < 12 months
- Have undergone a heart transplant or have recently been allocated a heart transplant donor
- Being enrolled in an interventional clinical study of another device or drug
- Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), dilated cardiomyopathy, or constrictive pericarditis
- Patients who are pregnant or planning to become pregnant within the next 12 months. Note: Female patients of childbearing age are required to undergo a pregnancy test within 14 days prior to the operation and the result should be negative, and additionally they should use a confirmed method of contraception
- Other conditions that the investigator considers inappropriate for participation in this clinical study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Multicenter, Single-group Target Value Clinical Study to Evaluate the Safety and Efficacy of JensClip Transcatheter Valve Repair System in the Treatment of Moderate to Severe Degenerative Mitral Regurgitation
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators.
Read the detailed description
Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk.
- Being tested
- JensClip transcatheter valve repair system
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JensClip transcatheter valve repair systemDevice
Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.
| Study group | Role | What they receive |
|---|---|---|
| JensClip transcatheter valve repair system | Experimental | Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk. Receives: Device: JensClip transcatheter valve repair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success rate at 12 months postoperatively
Clinical success is defined as no death, no mitral valve-related surgical procedures due to mitral valve incompetence, and no moderate-severe or severe mitral regurgitation (MR > 2+), with the primary evaluation indicators determined by the Core Laboratory and Clinical Event Committee (CEC).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenscare Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shengshou Hu, Principal investigator, FUWAI YUNAN CARDIOVASCULAR HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417945
- Sponsor's protocol ID
- LT-2021-06
- Status last verified
- Jun 2022
- First submitted
- 6 Jun 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-group Target Value Clinical Study to Evaluate the Safety and Efficacy of JensClip Transcatheter Valve Repair System in the Treatment of Moderate to Severe Degenerative Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05417945
- Acronym / sponsor ID
- LT-2021-06
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Jenscare ScientificIndustry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jun 2022 (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.
The clinical trial study is designed as a prospective, multicenter, single-group target value clinical study to evaluate the safety and efficacy of the clinical investigational product and to evaluate its performance using the above clinical trial primary endpoint and secondary endpoint indicators.
Detailed description
Transcatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation.Using the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JensClip transcatheter valve repair system | Experimental | Device: JensClip transcatheter valve repair systemUsing the JensClip transcatheter valve repair system for the treatment of patients with moderate-severe or severe degenerative mitral regurgitation who are at high surgical risk. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Echocardiographically confirmed moderate-severe or severe degenerative mitral regurgitation (regurgitation degree MR ≥ 3+);
- NYHA Classification II-IV.
- LVEF ≥ 20%
- Patients considered at high surgical risk after evaluation by two or more cardiovascular specialists (American Association for Thoracic Surgery STS score: risk of death from mitral valve repair ≥ 6% or from mitral valve replacement ≥ 8% (high risk); or the presence of 2 or more indices of frailty (moderate to severe frailty); or the presence of 2 or more major organ insufficiencies that do not improve postoperatively; or a comprehensive cardiac team assessment that the patient has other combined diseases or factors that make him or her unsuitable for surgery)
Key exclusion criteria (22 listed)
- Severe mitral valve calcification
- Previous implantation of a prosthetic mitral valvuloplasty ring or prosthetic mitral valve, or previous transcatheter mitral valve surgery
- Patients with active infective endocarditis
- Patients with mitral stenosis
- Any intracardiac mass, left ventricular or atrial thrombus detected by echocardiography
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 |
|---|---|---|
| JensClip transcatheter valve repair systemTranscatheter mitral valve repair system is derived from the "Edge-to-Edge" technique in traditional surgery. The principle is roughly to clamp the midpoint of the anterior leaflet and the midpoint of the posterior leaflet of the mitral valve to form a double-hole inflow channel and then improve the regurgitation. | Device | JensClip transcatheter valve repair system |
Primary outcome
Clinical success rate at 12 months postoperatively
Time frame: 12 months
Clinical success is defined as no death, no mitral valve-related surgical procedures due to mitral valve incompetence, and no moderate-severe or severe mitral regurgitation (MR > 2+), with the primary evaluation indicators determined by the Core Laboratory and Clinical Event Committee (CEC).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Shengshou Hu principal investigator
FUWAI YUNAN CARDIOVASCULAR HOSPITAL
Questions about this trial
What is this clinical trial studying?
A study testing JensClip transcatheter valve repair system in people with Degenerative Mitral Valve Disease and Mitral Valve Regurgitation, run by Jenscare Scientific.
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 7 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: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengshou Hu (18616900716, guyongxin@jenscare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success rate at 12 months postoperatively (time frame: 12 months). 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 14 Jun 2022.