Evaluate the Safety and Efficacy of the ValveClampCLAMPNCT03869164
Multi-center Trial of ValveClamp
A study testing ValveClamp in people with Evaluate the Safety and Efficacy of the ValveClamp, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Evaluate the Safety and Efficacy of the ValveClamp
- What is being tested?
- ValveClamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 12 Feb 2019to 8 Dec 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age older than 60 years;
- moderate to severe or severe mitral regurgitation;
- symptoms (New York Heart Association [NYHA] cardiac function class ≥2) related to MR;
- the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
- high risk for surgery according the MVARC criteria;
- providing signed informed consent.
Who cannot join
- acute myocardial infarction in the prior 4 weeks of the intended treatment;
- any interventional or surgical cardiac procedure performed within 30 days prior;
- the need for any other cardiac surgery;
- echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- life expectancy within 12 months;
- moderate or severe aortic stenosis or regurgitation;
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- mitral valve orifice area <3.5 cm2;
- untreated significant coronary stenosis;
- history of mitral valvuloplasty;
- Infective endocarditis and rheumatic heart disease;
- untreated cardiogenic shock, acute pulmonary congestion;
- unfavored mitral valve anatomy that may preclude device implantation including: calcification or significant cleft in area of the A2 and/or P2 scallops, significant regurgitation beyond A2 or P2 scallops and short posterior leaflet (<10mm).
- Other clinical trials that the subjects participated in have not reached the end point.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hopital of Fudan University
Shanghai, Shanghai, China, 200032
Wenzhi Pan, M.D.
About this study
Official title: Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
Read the detailed description
The transcatheter edge-to-edge mitral valve repair device MitraClip (Abbott Vascular, Santa Clara, CA, USA) is the most mature device for mitral regurgitation. Another transcatheter edge-to-edge mitral valve repair device, the PASCAL system, has been shown to be feasible to reduce MR severity. Both the MitraClip and PASCAL devices need a complex steerable deliver system and thus complex process to steer the device to mitral valve. An easy-to-operate transcatheter edge-to-edge mitral valve repair system (ValveClamp) with larger coaptation width was thus recently developed in China. The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
- Being tested
- ValveClamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValveClampDevice
ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width
| Study group | Role | What they receive |
|---|---|---|
| ValmpClamp Arm | Experimental | Not described Receives: Device: ValveClamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
The device success rate
freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month.
Measured: 12months
Secondary outcomes (7)
Incidence of adverse cardiovascular events
death, severe arrhythmia, pericardial tamponade, emergency surgery, cardiac shock, endocarditis, bleeding , and other complications caused by procedure
Measured: immediate post-operation
Incidence of deaths
All cause deaths (cardiac death, and non cardiac death) or strokes
Measured: 1,6,12months
Incidence of mitral valve re-surgery
Mitral valve re-surgery because of the failure of operation, embolism, clamp's falling off.
Measured: 1,6,12months
Grading of mitral regurgitation by echocardiography
The echocardiographic analysis was performed according to the American Society of Echocardiography guidelines. The severity of MR was graded as none or trac e (0+), mild(1+), moderate(2+), moderate to severe (3+) or severe (4+) by using the EVERST criteria.
Measured: 1,6,12months
New York Heart Association (NYHA) class
The NYHA cardiac function class containing the levels of Ⅰ, Ⅱ, Ⅲ, Ⅳ, relies on the concept of ordinary physical activities. Class Ⅰ means that patients have cardiac disease but without the resulting limitations of physical activity. Class Ⅱ means that patients have cardiac disease resulting in slight limitation of physical activity. Class Ⅲ refers to that patients have cardiac disease resulting in marked limitation of physical activity. Class Ⅳ refers to that patients have cardiac disease resulting in inability to carry on any physical activity without discomfort.
Measured: 1,6,12months
brain natriuretic peptide
BNP is a kind of laboratory blood test index to reflect the cardiac function.
Measured: 1,6,12months
severe adverse events
Severe adverse events include injury of mitral valves, re-inpatient for poor cardiac function and other severe adverse events.
Measured: 1,6,12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start12 Feb 2019
- Primary completion13 Dec 2021 (estimated)
- Study completion8 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Safety and Efficacy of the ValveClampStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenzhi Pan, M.D., Principal investigator, Department of Cardiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869164
- Sponsor's protocol ID
- YL-2018-27
- Acronym
- CLAMP
- Status last verified
- May 2020
- First submitted
- 25 Feb 2019
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Trial of Transcatheter Edge-to-edge Mitral Valve Repair With ValveClamp System in High Risk Patients With Degerative Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT03869164
- Acronym / sponsor ID
- CLAMP / YL-2018-27
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 13 Dec 2021 (estimated)
- Study completion
- 8 Dec 2025 (estimated)
- First posted
- 11 Mar 2019 (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 ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
Detailed description
The transcatheter edge-to-edge mitral valve repair device MitraClip (Abbott Vascular, Santa Clara, CA, USA) is the most mature device for mitral regurgitation. Another transcatheter edge-to-edge mitral valve repair device, the PASCAL system, has been shown to be feasible to reduce MR severity. Both the MitraClip and PASCAL devices need a complex steerable deliver system and thus complex process to steer the device to mitral valve. An easy-to-operate transcatheter edge-to-edge mitral valve repair system (ValveClamp) with larger coaptation width was thus recently developed in China. The ValveClamp (Hanyu Medical Technology, Shanghai, China) is the first edge-to-edge mitral valve repair system for interventional operation in China, which is composed of the front clamp, the rear clamp and the closed ring. The purpose of the multi-center trial is to evaluate the safety and efficacy of the ValveClamp for degenerative mirtal regurgistation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ValmpClamp Arm | Experimental | Device: ValveClamp |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age older than 60 years;
- moderate to severe or severe mitral regurgitation;
- symptoms (New York Heart Association [NYHA] cardiac function class ≥2) related to MR;
- the primary regurgitant jet originated from malcoaptation of the A2 and P2 scallops of the mitral valve;
- high risk for surgery according the MVARC criteria;
Key exclusion criteria (13 listed)
- acute myocardial infarction in the prior 4 weeks of the intended treatment;
- any interventional or surgical cardiac procedure performed within 30 days prior;
- the need for any other cardiac surgery;
- echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- life expectancy within 12 months;
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 |
|---|---|---|
| ValveClampValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width | Device | ValmpClamp Arm |
Primary outcome
The device success rate
Time frame: 12months
freedom from the composite end point of death from any cause, surgery for valve dysfunction, and MR ≥3+ at one month.
7 secondary outcomes
Incidence of adverse cardiovascular events
Time frame: immediate post-operation
Incidence of deaths
Time frame: 1,6,12months
Incidence of mitral valve re-surgery
Time frame: 1,6,12months
Grading of mitral regurgitation by echocardiography
Time frame: 1,6,12months
New York Heart Association (NYHA) class
Time frame: 1,6,12months
brain natriuretic peptide
Time frame: 1,6,12months
severe adverse events
Time frame: 1,6,12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
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.
Wenzhi Pan, M.D. principal investigator
Department of Cardiology, Zhongshan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ValveClamp in people with Evaluate the Safety and Efficacy of the ValveClamp, run by Shanghai Zhongshan Hospital 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 6 inclusion and 13 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 27 May 2020. 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?
Contact Wenzhi Pan, M.D. (13774475922, peden@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The device success rate (time frame: 12months). 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 27 May 2020.