Mitral RegurgitationNCT04528576
Dragonfly-M Early Feasibility Study
A study testing Dragonfly mitral valve repair system in people with Mitral Regurgitation, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.
Trial summary
To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Dragonfly mitral valve repair system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2020to 31 Dec 2023
- 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 yrs
- Moderate-to-severe (3+) or severe (4+) mitral valve regurgitation on transthoracic or transesophageal echocardiography, and confirmed by echocardiographic core laboratory
- The patient is on optimal guideline directed medical therapy for heart failure and remains symptomatic.
- High or prohibitive surgical risk as defined by either Society for Thoracic Surgery Risk Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points , prohibitive risk as determined by the clinical judgement of the site heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experience in mitral valve disease, due to the presence of one or more documented surgical risk factors.
- Anatomically suitable for mitral valve repair and can be treated by Dragonfly confirmed by both site investigators, echocardiographic core laboratory, and the eligibility committee.
- Transseptal catheterization and femoral vein access is determined to be feasible
- Life expectancy ≥ 12 months
- The subject or the subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests and follow-ups, and has provided written informed consent
Who cannot join
- History of heart transplantation, prior mitral valve replacement surgery. or transcatheter mitral valve procedure;
- Leaflet anatomy which may preclude Dragonfly-MTM implantation and position, as judged by the site investigators and confirmed by the echocardiographic core laboratory and eligibility committee
- Evidence of calcification or significant cleft in the grasping area
- LVEF < 20%
- LVESD≥ 60mm;
- Mobile leaflet length<10mm
Show all 26Show fewer
- Mitral valve effective orifice area (EOA) < 3.5cm2 or in the opinion of site investigators and confirmed by the echocardiographic core laboratory and eligibility committee that mitral stenosis would result from implantation of the Dragonfly-MTM device.
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
- Severe non-mitral valve disease requiring treatment .
- Severe pulmonary artery hypertension (sPAP>70mmHg)
- Severe right ventricular dysfunction;
- Active endocarditis or previous mitral valve endocarditis; Active rheumatic heart disease or leaflets degenerated from rheumatic disease
- Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment；
- Extreme frailty
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis and any other structural heart disease causing heart failure other than dilated cardiomyopathy;
- Renal failure requiring dialysis;
- Blood cachexia including granulocytopenia (WBC < 3×109/L), acute anemia (HB < 90g/L), thrombocytopenia (PLT < 50×109/L), severe coagulopathy, and contradictions of anticoagulant and antiplatelet agents;
- Evidence of an acute myocardial infarction in the prior 4 weeks;
- Evidence of a shock in the prior 90 days;
- Any percutaneous cardiac intervention or carotid surgery or any cardiac surgery within the 30 days prior to randomization;
- Evidence of acute peptic ulcer upper or gastrointestinal hemorrhage in the prior 90 days;
- Severe symptomatic carotid artery stenosis over 70% confirmed by echocardiography;
- The subjects suffer from diseases which may lead difficulty in evaluating treatment (e.g., cancer, infection, severe metabolic disease, psychosis, etc.); or special cases that were evaluated by the heart team of local experimental center as not suitable for the surgical application of this clinical trial;
- Life expectancy ≤ 12 months;
- Subject participating in an investigational drug or another device study within the past 1 month;
- In the judgment of the investigator, subjects may not complete the trial according to poor compliance.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study
To establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Read the detailed description
The subjects with moderate-to-severe (3+) and severe (4+) mitral valve regurgitation (MR) at high or prohibitive surgical risk will be evaluated by the study sites, and study eligibility confirmed by the echocardiographic core laboratory and eligibility committee. Those qualifying will then be treated with Dragonfly transcatheter mitral valve repair system after signing the informed consent. The follow-up will be conducted at discharge, 30 days, 6 months and 12 months after the operation. The primary endpoints are the incidence of major adverse events (MAE) at 30 days, and acute procedural success. Acute procedural success is defined as placement of one or more Dragonfly devices on the mitral valve with reduction of MR to 2+ or less. The secondary endpoints include all-cause mortality, cardiovascular mortality, incidence of serious adverse event, cardiovascular rehospitalization, NYHA functional class, mitral valve hemodynamics, acute technical success rate and device success rate at 6 months. Acute technical success is defined as no procedural mortality, successful in access, delivery, and retrieval of the device delivery system, and no emergency surgery or reintervention related to the device or access procedure in the catheterization laboratory. Device success is defined as no procedural mortality, proper delivery and deployment of the device, no unplanned surgical or interventional procedures related to the device, no specific device-related technical failure and or complications, function improvement of MR without significant stenosis (MR ≤ 2+) and without associated hemolysis or thrombogenesis.
- Conditions
- Mitral Regurgitation
- Being tested
- Dragonfly mitral valve repair system
- Keywords
- mitral regurgitation, TMVr
- 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.
Dragonfly mitral valve repair systemDevice
With transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system
| Study group | Role | What they receive |
|---|---|---|
| DragonFly-M | Experimental | Experimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Meditech Co., Ltd Receives: Device: Dragonfly mitral valve repair system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute procedural success
The acute procedural success is defined as successful Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of mitral valve prior to 30 days is defined as acute procedure failure
Measured: 1 month
Incidence of major adverse event (MAE) at 30 days
Major adverse event is defined as one of the following components: death, myocardial infarction (MI), stroke, renal failure requiring dialysis, and cardiac surgery for Dragonfly device failure.
Measured: 1 month
Secondary outcomes (6)
All-cause mortality
Death from any cause
Measured: 6 months
Cardiovascular mortality
Death from cardiac causes
Measured: 6 months
Incidence of serious adverse event (SAE）
If the adverse event meets any of the criteria below, it is regarded as a serious adverse event (SAE): 1) results in death; 2) is life threatening, results in illness or injury; 3) requires inpatient hospitalization or prolongation of existing hospitalization; 4) results in a persistent or significant disability/incapacity; 5) results in a congenital anomaly/birth defect, fetal death, fetal distress; 6) results in medical or surgical intervention to prevent permanent impairment to body structure or a body function; 7) an important medical event that may not result in death, be life-threatening, or require hospitalization but may be considered serious when, based upon appropriate medical judgment, may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed in this definition.
Measured: 6 months
NYHA
NYHA functional class
Measured: 6 months
Technical success
must meet all of the following items: 1) no procedural mortality; and 2) successful in access, delivery, and retrieval of the device delivery system; and 3) no emergency surgery or reintervention related to the device or access procedure.
Measured: Immediately after procedure
Device success
must meet all of the following items:1) No procedural mortality; 2) Proper delivery and deployment of the device; 3) No unplanned surgical or interventional procedures related to the device; 4) No specific device-related technical failure or complication. 5) Improvement of MR without significant stenosis (MR ≤ 2+) without associated hemolysis or thrombogenesis.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start23 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Model description
- The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transseptal mitral valve repair using Dragonfly mitral valve repair system.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Valgen Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- jianan Wang, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528576
- Sponsor's protocol ID
- DragonFly-M-2020
- Status last verified
- Aug 2021
- First submitted
- 23 Aug 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu X, Chen M, Han Y, Pu Z, Lin X, Feng Y, Xu K, Lam YY, Lim DS, Wang J. First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation. JACC Asia. 2022 Jun 21;2(3):390-394. doi: 10.1016/j.jacasi.2022.03.010. eCollection 2022 Jun.
PubMed 36338402
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dragonfly-M Transcatheter Mitral Valve Repair System Early Feasibility Study
- ClinicalTrials.gov ID
- NCT04528576
- Acronym / sponsor ID
- DragonFly-M-2020
- Conditions
- Mitral Regurgitation
- Keywords
- mitral regurgitation, TMVr
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hangzhou Valgen Medtech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 27 Aug 2020 (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 establish the safety and effectiveness of the DragonFly transcatheter mitral valve repair system in symptomatic patients with moderate to severe and severe mitral regurgitation who have been determined to be at an high risk of mortality with mitral valve surgery by the cardiac surgeon with concurrence by the local Heart Team
Detailed description
The subjects with moderate-to-severe (3+) and severe (4+) mitral valve regurgitation (MR) at high or prohibitive surgical risk will be evaluated by the study sites, and study eligibility confirmed by the echocardiographic core laboratory and eligibility committee. Those qualifying will then be treated with Dragonfly transcatheter mitral valve repair system after signing the informed consent. The follow-up will be conducted at discharge, 30 days, 6 months and 12 months after the operation. The primary endpoints are the incidence of major adverse events (MAE) at 30 days, and acute procedural success. Acute procedural success is defined as placement of one or more Dragonfly devices on the mitral valve with reduction of MR to 2+ or less. The secondary endpoints include all-cause mortality, cardiovascular mortality, incidence of serious adverse event, cardiovascular rehospitalization, NYHA functional class, mitral valve hemodynamics, acute technical success rate and device success rate at 6 months. Acute technical success is defined as no procedural mortality, successful in access, delivery, and retrieval of the device delivery system, and no emergency surgery or reintervention related to the device or access procedure in the catheterization laboratory. Device success is defined as no procedural mortality, proper delivery and deployment of the device, no unplanned surgical or interventional procedures related to the device, no specific device-related technical failure and or complications, function improvement of MR without significant stenosis (MR ≤ 2+) and without associated hemolysis or thrombogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The clinical trial was designed as a single group assignment study. The participants with moderate to severe and severe mitral valve regurgitation will receive a transseptal mitral valve repair using Dragonfly mitral valve repair system.
| Arm | Type | Receives |
|---|---|---|
| DragonFly-M | Experimental | Device: Dragonfly mitral valve repair systemExperimental group is allocated to use novel mitral valve repair system manufactured by Hangzhou Valgen Meditech Co., Ltd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 yrs
- Moderate-to-severe (3+) or severe (4+) mitral valve regurgitation on transthoracic or transesophageal echocardiography, and confirmed by echocardiographic core laboratory
- The patient is on optimal guideline directed medical therapy for heart failure and remains symptomatic.
- High or prohibitive surgical risk as defined by either Society for Thoracic Surgery Risk Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points , prohibitive risk as determined by the clinical judgement of the site heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experience in mitral valve disease, due to the presence of one or more documented surgical risk factors.
- Anatomically suitable for mitral valve repair and can be treated by Dragonfly confirmed by both site investigators, echocardiographic core laboratory, and the eligibility committee.
Key exclusion criteria (26 listed)
- History of heart transplantation, prior mitral valve replacement surgery. or transcatheter mitral valve procedure;
- Leaflet anatomy which may preclude Dragonfly-MTM implantation and position, as judged by the site investigators and confirmed by the echocardiographic core laboratory and eligibility committee
- Evidence of calcification or significant cleft in the grasping area
- LVEF < 20%
- LVESD≥ 60mm;
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 |
|---|---|---|
| Dragonfly mitral valve repair systemWith transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system | Device | DragonFly-M |
Primary outcome
Incidence of acute procedural success
Time frame: 1 month
The acute procedural success is defined as successful Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of mitral valve prior to 30 days is defined as acute procedure failure
Incidence of major adverse event (MAE) at 30 days
Time frame: 1 month
Major adverse event is defined as one of the following components: death, myocardial infarction (MI), stroke, renal failure requiring dialysis, and cardiac surgery for Dragonfly device failure.
6 secondary outcomes
All-cause mortality
Time frame: 6 months
Cardiovascular mortality
Time frame: 6 months
Incidence of serious adverse event (SAE）
Time frame: 6 months
NYHA
Time frame: 6 months
Technical success
Time frame: Immediately after procedure
Device success
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Derived from this study: PubMed 36338402Liu X, Chen M, Han Y, Pu Z, Lin X, Feng Y, Xu K, Lam YY, Lim DS, Wang J. First-in-Human Study of the Novel Transcatheter Mitral Valve Repair System for Mitral Regurgitation. JACC Asia. 2022 Jun 21;2(3):390-394. doi: 10.1016/j.jacasi.2022.03.010. eCollection 2022 Jun.
- 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.
jianan Wang, PhD principal investigator
Zhejiang 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 Dragonfly mitral valve repair system in people with Mitral Regurgitation, run by Hangzhou Valgen Medtech 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 8 inclusion and 26 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 29 Mar 2022. 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?
Incidence of acute procedural success (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04528576, which also lists 1 linked publication.
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 29 Mar 2022.