Functional Mitral RegurgitationNCT05931900
The JensClip Transcatheter Valve Repair System for Treating Functional Mitral Regurgitation
A study testing moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients in people with Functional Mitral Regurgitation, run by Jenscare Scientific at 1 site in China.
Trial summary
To evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still symptomatic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Mitral Regurgitation
- What is being tested?
- moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteChina
- Study dates
- Aug 2023to Aug 2025
- 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;
- Patients with symptomatic FMR due to ischemic or non-ischemic cardiomyopathy with moderate-severe or greater mitral regurgitation (MR ≥ 3+) confirmed by echocardiography;
- Patients that have undergone adequate treatment, including treatment for conditions such as coronary artery disease, left ventricular dysfunction, heart failure, and mitral regurgitation (e.g., coronary revascularization, cardiac resynchronization therapy, and/or guideline-directed medication therapy (GDMT) at a stable dose), as judged by the local hospital heart team; Note: Any change in GDMT with ≥ 100% increase or ≥ 50% decrease in dose is considered "unstable".
- NYHA cardiac function classification ≥ Class II;
- Left ventricular ejection Fraction (LVEF) ≥ 20%;
- Left ventricular end systolic diameter (LVESD) ≤ 70 mm;
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- At least one hospitalization for heart failure in the past 12 months and/or after adequate treatment, corrected BNP >150 pg/ml or corrected NT-proBNP > 600 pg/ml (correction method: If the patient has a body mass index (BMI) ≥ 20 kg/m2, BNP or NT-proBNP decreases by 4% for each 1 kg/m2 increase);
- Subjects with mitral valves anatomically suitable for mitral valve repair using this investigational device;
- Subjects who fully understand the trial protocol and purpose, voluntarily participate in the trial and sign the informed consent form, and are willing to undergo relevant examinations and clinical follow-ups.
Who cannot join
- A history of mitral valve surgery or combined valvular disease requiring surgical or interventional treatment;
- Active rheumatic heart disease, infective endocarditis;dian
- Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), constrictive pericarditis;
- Left intracardiac masses, bulges, thrombi and/or mitral valve leaflets, tendinopathy indicated by imaging;
- Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term steroid hormone medication;
- Severe right heart insufficiency or 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);
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- Patients who have had an acute myocardial infarction, stroke/transient ischemic attack (TIA) and/or gastrointestinal bleeding within 30 days; Patients who have undergone any transcatheter cardiovascular intervention, carotid artery surgery, pacemaker implantation, cardiac resynchronization therapy (CRT-P, CRT-D) or implantable cardioverter defibrillator (ICD) within 30 days, or cardiovascular surgery within 180 days;
- Hemodynamic instability, with systolic blood pressure < 90 mmHg in the absence of afterload-reducing drugs, or cardiogenic shock or the need for vasoactive drugs, intra-aortic balloon pump, left ventricular assist devices, etc.;
- Patients with known bleeding disorders, coagulation disorders, and/or clear contraindications to the use of anticoagulants and antiplatelet agents;
- Known hypersensitivity to product composition;
- Patients with clear contraindications to transesophageal echocardiography, contraindications to tracheal intubation, and/or the presence of contraindications to general anesthesia;
- Modified Rakin score ≥ 4;
- Patients with a life expectancy of < 12 months or who have undergone a heart transplant or are scheduled to have a heart transplant within 12 months after surgery;
- Patients who are enrolled in other drug or device clinical trials and have not completed follow-up of the primary endpoint;
- Pregnant or breastfeeding women or those planning to become pregnant within the next 12 months;
- Other conditions that the investigator considers inappropriate to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Single Group Target Value Study for Evaluating the Safety and Effectiveness of JensClip Transcatheter Valve Repair System in The Treatment of Functional Mitral Regurgitation
To evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still symptomatic.
Read the detailed description
The clinical trial study is designed as a prospective, multicenter, single-group target-value clinical study with single-armed target value. Subjects are patients with moderate-severe or greater (MR ≥ 3+) FMR who have received adequate treatment but are still symptomatic. The safety and efficacy of the investigational product and its performance are evaluated using the above clinical trial primary endpoint and secondary endpoint indicators. All subjects in this study will be followed up at 30 days, 3 months, 6 months, and 12 months after device implantation, and clinical data obtained will be analyzed and summarized, and clinical reports will be used for submission for product registration. The study will continue to follow up subjects for 2-5 years after surgery to observe the occurrence of adverse events and to make an accurate and credible evaluation of the long-term safety and efficacy of this investigational product. All relevant clinical data will be collected, organized and statistically analyzed by an independent data management and statistics center and clinical monitoring organization. The core laboratory assesses the relevant imaging data during the clinical trial, and the CEC (Clinical Event Committee) is specially established to determine the endpoint events of the clinical trial. The clinical study consists of two phases: the first phase is a feasibility (FIM) clinical trial and the second phase is a confirmatory clinical trial; the sample size of the FIM clinical trial is not included in the second phase.
- Conditions
- Functional Mitral Regurgitation
- Being tested
- moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patientsDevice
Functional mitral regurgitation (FMR) is common in patients with myocardial infarction or dilated cardiomyopathy, and portends a poor prognosis despite guideline-directed medical therapy (GDMT).
| Study group | Role | What they receive |
|---|---|---|
| moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients | Experimental | Functional mitral regurgitation (FMR) is common in patients with myocardial infarction or dilated cardiomyopathy, and portends a poor prognosis despite guideline-directed medical therapy (GDMT). Receives: Device: moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality or hospitalization rate
All-cause mortality or hospitalization rate for heart failure 12 months after surgery.
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 posted5 Jul 2023
- Study startAug 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Mitral RegurgitationStudies 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
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jenscare Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931900
- Sponsor's protocol ID
- LT-2022-07
- Status last verified
- Jun 2023
- First submitted
- 19 Jun 2023
- Last updated
- 5 Jul 2023
- 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Group Target Value Study for Evaluating the Safety and Effectiveness of JensClip Transcatheter Valve Repair System in The Treatment of Functional Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05931900
- Acronym / sponsor ID
- LT-2022-07
- Conditions
- Functional Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Jenscare ScientificIndustry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Jul 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 evaluate the efficacy and safety of the JensClip transcatheter valve repair system for patients with moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) who have received adequate treatment but are still symptomatic.
Detailed description
The clinical trial study is designed as a prospective, multicenter, single-group target-value clinical study with single-armed target value. Subjects are patients with moderate-severe or greater (MR ≥ 3+) FMR who have received adequate treatment but are still symptomatic. The safety and efficacy of the investigational product and its performance are evaluated using the above clinical trial primary endpoint and secondary endpoint indicators. All subjects in this study will be followed up at 30 days, 3 months, 6 months, and 12 months after device implantation, and clinical data obtained will be analyzed and summarized, and clinical reports will be used for submission for product registration. The study will continue to follow up subjects for 2-5 years after surgery to observe the occurrence of adverse events and to make an accurate and credible evaluation of the long-term safety and efficacy of this investigational product. All relevant clinical data will be collected, organized and statistically analyzed by an independent data management and statistics center and clinical monitoring organization. The core laboratory assesses the relevant imaging data during the clinical trial, and the CEC (Clinical Event Committee) is specially established to determine the endpoint events of the clinical trial. The clinical study consists of two phases: the first phase is a feasibility (FIM) clinical trial and the second phase is a confirmatory clinical trial; the sample size of the FIM clinical trial is not included in the second phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients | Experimental | Device: moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patientsFunctional mitral regurgitation (FMR) is common in patients with myocardial infarction or dilated cardiomyopathy, and portends a poor prognosis despite guideline-directed medical therapy (GDMT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years;
- Patients with symptomatic FMR due to ischemic or non-ischemic cardiomyopathy with moderate-severe or greater mitral regurgitation (MR ≥ 3+) confirmed by echocardiography;
- Patients that have undergone adequate treatment, including treatment for conditions such as coronary artery disease, left ventricular dysfunction, heart failure, and mitral regurgitation (e.g., coronary revascularization, cardiac resynchronization therapy, and/or guideline-directed medication therapy (GDMT) at a stable dose), as judged by the local hospital heart team; Note: Any change in GDMT with ≥ 100% increase or ≥ 50% decrease in dose is considered "unstable".
- NYHA cardiac function classification ≥ Class II;
- Left ventricular ejection Fraction (LVEF) ≥ 20%;
Key exclusion criteria (16 listed)
- A history of mitral valve surgery or combined valvular disease requiring surgical or interventional treatment;
- Active rheumatic heart disease, infective endocarditis;dian
- Patients diagnosed with hypertrophic cardiomyopathy, restrictive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis), constrictive pericarditis;
- Left intracardiac masses, bulges, thrombi and/or mitral valve leaflets, tendinopathy indicated by imaging;
- Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term steroid hormone medication;
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 |
|---|---|---|
| moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patientsFunctional mitral regurgitation (FMR) is common in patients with myocardial infarction or dilated cardiomyopathy, and portends a poor prognosis despite guideline-directed medical therapy (GDMT). | Device | moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients |
Primary outcome
All-cause mortality or hospitalization rate
Time frame: 12 months
All-cause mortality or hospitalization rate for heart failure 12 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- 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.
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 moderate-severe or greater (MR ≥ 3+) functional mitral regurgitation (FMR) patients in people with Functional Mitral Regurgitation, run by Jenscare Scientific 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 16 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 5 Jul 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?
Results are not available in the source record.
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?
All-cause mortality or hospitalization rate (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 5 Jul 2023.