Mitral RegurgitationNCT05391802
The Multicenter Clinical Trial of a Novel TEER Decive (V-CLASP Trial)
A study testing Transcatheter mitral valve repair in people with Mitral Regurgitation, run by Shanghai Zhongshan Hospital.
Trial summary
This is a single-group, prospective, multicenter clinical research using the single-arm objective performance criteria. Patients with moderate to severe mitral regurgitation and a high surgical risk will be treated with ValveClasp®, a novel transcatheter mitral edge-to-edge repair system. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Transcatheter mitral valve repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 30 Jun 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male or female, ≥70 years old.
- The existence of primary mitral regurgitation of moderate to severe severity or more was established by transthoracic echocardiogram (TTE) or transesophageal echocardiography (TEE) within 3 months previous to inclusion.
- NYHA class II-IV, symptomatic subject.
- The subject's left ventricular ejection fraction (LVEF) was less than 20% within the three months preceding to enrolment, as determined by any of the following methods: echocardiography, left ventriculography, or cardiac magnetic resonance imaging (MRI) (not visual assessment).
- Subjects were evaluated for cardiac anatomical fitness for mitral valve repair surgery as well as suitability for the research device.
- Subjects were evaluated for femoral access appropriateness and atrial septal puncture feasibility.
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- Patients who have been assessed as having a high or very high surgical risk by the cardiac specialists at each clinical trial location. The most important factor in their decision *Score from the American Association for Thoracic Surgery (STS): 8% for surgical mitral valve replacement and 8% for surgical mitral valve repair.
- STS score of 8% for surgical mitral valve replacement or 6% for surgical mitral valve repair, or the presence of additional surgical high-risk variables (such as significant weakness or the presence of two or more patients).
- severe frailty, more than two uncorrectable organ failures, and surgical-related impairments (history of open heart surgery, extremely severe thoracic deformity, and so on), with STS ratings based on the website version accessible at the time of registration.
- According to the 2020 AHA/ACC Guidelines for Valve Management, high risk for mitral valve surgery is defined by FDA and MVARC criteria.
- The patient is willing and capable of adhering to the protocol's requirements and data collecting methods, understands the trial's aim, and freely participates in and signs the clinical study by himself or a legal guardian. (8) The participant consents willingly and signs a written informed consent form authorized by the Clinical Trial Ethics Committee.
Who cannot join
- After heart transplantation, mitral valve surgery or mitral valve transcatheter surgery
- Acute myocardial infarction within 1 month.
- Any vascular intervention or surgical procedure within 1 month.
- The investigator determines that the subject's femoral vein cannot accommodate the largest size catheter in the test product or an ipsilateral deep vein thrombosis.
- The subject has a medical condition that would make evaluation of treatment difficult (e.g., cancer, infection, severe metabolic disease, severe neurological
- Have a disease that would make evaluation of treatment difficult (e.g., cancer, infection, severe metabolic disease, severe neurological lesions affecting cognitive ability, psychiatric disease, etc.); or special cases that have been evaluated by the local trial center cardiac team as inappropriate for (4) Surgical studies related to this clinical trial device. (6) Severe non-mitral valve disease requiring urgent management and other cardiac surgical procedures.
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- Severe mitral valve calcification; leaflet anatomy not conducive to mitral valve clip placement.
- Severe pulmonary hypertension (pulmonary artery systolic pressure >90 mmHg as measured by echocardiography).
- Untreated controlled acute pulmonary edema. (10) Severe right heart insufficiency. (11) Bleeding disorders or disorders of coagulation; or the presence of contraindications to antithrombotic therapy (12) Active infection requiring current antibiotic therapy (in the case of transient disease, the patient will not be enrolled until at least 14 days after discontinuation of antibiotics).
- Active infection requiring current antibiotic therapy (in the case of temporary disease, patients should be off antibiotics for at least 14 days before being enrolled). Patients must be free of infection prior to treatment and required dental treatment should be completed at least 21 days prior to treatment.
- History of acute peptic ulcer or gastrointestinal bleeding within 2 months.
- Untreated severe coronary artery stenosis requiring hemodialysis (15) Ultrasound showing intracardiac thrombus, bulky mass, or mass. (16) History of infective endocarditis, rheumatic heart disease. (17) Hemodynamic instability, defined as systolic blood pressure <90 mmHg without afterload-reducing drugs, uncorrected cardiogenic shock or the use of intra-aortic balloon counterpulsation. (18) Patients with contraindications to transesophageal echocardiography (TEE) and contraindications to general anesthesia.
- Patients with allergies or contraindications to study devices or surgical drugs that cannot be adequately managed by medical means (20) Life expectancy <12 months due to concomitant non-cardiac comorbidities. (21) Subjects are participating in other clinical trials that have not met the observed endpoints or that would clinically interfere with this clinical trial (21) An experimental drug or other device study in which the subject is participating in another clinical trial that has not met the observed endpoint or would clinically interfere with the study endpoint of this clinical trial. (Note: If a trial requires extended follow-up of a product that was investigational at the time of the trial but has since been marketed, the trial should be conducted in a manner that is consistent with the clinical trial. (Note: If a trial requires extended follow-up of a product that was investigational at the time of the trial but has since been marketed, the trial is not considered to be an investigational trial).
- Patients who, in the opinion of the investigator, are not suitable for enrollment in this trial.
About this study
Official title: A Multicenter, Prospective, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of the Transcatheter Mitral Valve Repair System: ValveClasp® in the Treatment of Moderate to Severe Mitral Regurgitation
This is a single-group, prospective, multicenter clinical research using the single-arm objective performance criteria. Patients with moderate to severe mitral regurgitation and a high surgical risk will be treated with ValveClasp®, a novel transcatheter mitral edge-to-edge repair system.
The subjects will be followed postoperatively, before discharge, for one month, six months, and twelve months. immediately following operation, before discharge, and at 1, 6, and 12 months after surgery, with follow-up at 2, 3, 4, and 5 years. The follow-ups began immediately before discharge and continued for one month, six months, and twelve months after surgery, with extensions to two, three, four, and five years.
- Conditions
- Mitral Regurgitation
- Being tested
- Transcatheter mitral valve repair
- 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.
Transcatheter mitral valve repairDevice
Transcatheter mitral valve repair (TMVr) is a minimally invasive procedure. Doctors place a thin tube (calleda catheter) into a large vein to reach your heart. A clip is then placed onto the center of your mitral valve. The valve continues to open and close, allowing blood to flow through while reducing MR.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients with PMR erolled in the trail will receive transcatheter mitral valve repair using the ValveClasp system Receives: Device: Transcatheter mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficiency rate
Treatment efficiency defined as no death, no incidence of mitral valve reoperation, MR ≤2+) at 12 months postoperatively.
Measured: 0-360 days
Secondary outcomes (1)
Operation success rate
Operation success defined as Successful device delivery, release, and implantation; implanted mitral valve clamps in the correct position; and implanted mitral valve clamps attaining the targeted efficacy (mitral regurgitation 2+ and mean transvalvular pressure difference 5 mmHg)
Measured: 0-360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start30 Jun 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391802
- Sponsor's protocol ID
- HYYL2022-02ZC-01
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 26 May 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Single-arm Objective Performance Criteria Trial to Evaluate the Safety and Efficacy of the Transcatheter Mitral Valve Repair System: ValveClasp® in the Treatment of Moderate to Severe Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05391802
- Acronym / sponsor ID
- HYYL2022-02ZC-01
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 May 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.
This is a single-group, prospective, multicenter clinical research using the single-arm objective performance criteria. Patients with moderate to severe mitral regurgitation and a high surgical risk will be treated with ValveClasp®, a novel transcatheter mitral edge-to-edge repair system.
The subjects will be followed postoperatively, before discharge, for one month, six months, and twelve months. immediately following operation, before discharge, and at 1, 6, and 12 months after surgery, with follow-up at 2, 3, 4, and 5 years. The follow-ups began immediately before discharge and continued for one month, six months, and twelve months after surgery, with extensions to two, three, four, and five years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Transcatheter mitral valve repairPatients with PMR erolled in the trail will receive transcatheter mitral valve repair using the ValveClasp system |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Male or female, ≥70 years old.
- The existence of primary mitral regurgitation of moderate to severe severity or more was established by transthoracic echocardiogram (TTE) or transesophageal echocardiography (TEE) within 3 months previous to inclusion.
- NYHA class II-IV, symptomatic subject.
- The subject's left ventricular ejection fraction (LVEF) was less than 20% within the three months preceding to enrolment, as determined by any of the following methods: echocardiography, left ventriculography, or cardiac magnetic resonance imaging (MRI) (not visual assessment).
- Subjects were evaluated for cardiac anatomical fitness for mitral valve repair surgery as well as suitability for the research device.
Key exclusion criteria (14 listed)
- After heart transplantation, mitral valve surgery or mitral valve transcatheter surgery
- Acute myocardial infarction within 1 month.
- Any vascular intervention or surgical procedure within 1 month.
- The investigator determines that the subject's femoral vein cannot accommodate the largest size catheter in the test product or an ipsilateral deep vein thrombosis.
- The subject has a medical condition that would make evaluation of treatment difficult (e.g., cancer, infection, severe metabolic disease, severe neurological
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 |
|---|---|---|
| Transcatheter mitral valve repairTranscatheter mitral valve repair (TMVr) is a minimally invasive procedure. Doctors place a thin tube (calleda catheter) into a large vein to reach your heart. A clip is then placed onto the center of your mitral valve. The valve continues to open and close, allowing blood to flow through while reducing MR. | Device | Treatment group |
Primary outcome
Treatment efficiency rate
Time frame: 0-360 days
Treatment efficiency defined as no death, no incidence of mitral valve reoperation, MR ≤2+) at 12 months postoperatively.
1 secondary outcome
Operation success rate
Time frame: 0-360 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter mitral valve repair in people with Mitral Regurgitation, run by Shanghai Zhongshan Hospital.
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 11 inclusion and 14 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 26 May 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?
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 efficiency rate (time frame: 0-360 days). 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 26 May 2022.