Mitral Valve InsufficiencyNCT05927441
DragonFly EU Pivotal Study
A study testing DragonFly Transcatheter Mitral Valve Repair System in people with Mitral Valve Insufficiency, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in Germany.
Trial summary
To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- DragonFly Transcatheter Mitral Valve Repair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old
- New York Heart Association (NYHA) Class II-IV
- Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography (For DMR cohort)
- Symptomatic FMR ≥ 3+ due to ischemic or non-ischemic cardiomyopathy (For FMR cohort)
- Transseptal catheterization and femoral vein access are determined to be feasible
- Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF
Who cannot join
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Other severe heart valve diseases requiring intervention
- Prior mitral valve leaflet surgery (prior annuloplasty ring not excluded) or previous transcatheter mitral valve intervention
- Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization
- Any cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to the procedure; or in the judgment of the investigator, the femoral vein cannot accommodate a 25 F catheter or the presence of an inferior vena cava filter would interfere with advancement of the catheter or ipsilateral deep vein thrombosis is present; or the patient's anatomy is not suitable for atrial septal puncture
- Patients in whom TEE or general anesthesia is contraindicated
Show all 18Show fewer
- End stage heart failure (ACC/AHA stage D); or after heart transplantation; or waiting for a heart transplantation
- Active endocarditis or active rheumatic heart disease; or mitral valve changes due to endocarditis and rheumatic heart valve disease
- History of ischemia cerebrovascular accident in the past 30 days, or severe symptomatic carotid stenosis (ultrasonic examination showed stenosis degree >70%); or carotid stent implantation within 30 days; hemorrhagic cerebrovascular accident occurred within 6 months
- History of acute peptic ulcer or gastrointestinal bleeding within 3 months
- Hemorrhagic disease or coagulation disorder; or contraindicated of antithrombotic drug treatment
- Modified Rankin scale ≥ 4
- Diseases that make the evaluation of treatment difficult (e.g., cancer, severe metabolic disease, psychosis)
- Pregnant or lactating women
- Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction medicine, or cardiogenic shock, or need for an intra-aortic balloon pump, or other hemodynamic support devices
- Active infections requiring current antibiotic therapy (if temporary illness, patients may be enrolled 2 weeks after discontinuation of antibiotics)
- Currently participating in an investigational drug or another device study of which the primary endpoint has not been completed, or it that clinically interferes with the current study endpoints. (Note: extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational study)
- In the judgment of the investigator, the patients' compliance will be poor and could not complete the study as required, or other conditions indicate that the subject is not suitable to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitatsklinikum Bonn Medizinische Klinik und Poliklinik
Bonn
About this study
Official title: Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation
To confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Read the detailed description
This is a prospective, multicentric clinical investigation.
Subjects to be included in this clinical investigation suffer from symptomatic chronic moderate-to-severe (3+) or severe (4+) DMR with high or prohibitive surgical risk judged by a local investigation site's heart team and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Local heart teams must include at a minimum a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease. After signing the informed consent form (ICF), a subject will be enrolled and treated with the DragonFlyTM Transcatheter Mitral Valve Repair System (Valgen Medtech, Hangzhou).
The CE-DMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. Group sequential design analysis is planned based on an adaptive design to assess whether the primary endpoint will be met. If the primary endpoint is not met at the interim analysis, then it will be re-analyzed for 160 patients when all subjects in Europe/Canada complete 12 months follow-up.
The CE-FMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. An adaptive design with sample size re-estimation will be incorporated. The primary endpoint will be assessed at the interim analysis. If the conditional power falls within the promising zone (38-80%), then the sample size will be re-estimated to maintain at least 80% power. Then the primary endpoint will be evaluated once the 12-month follow-up is completed with the larger sample size (not less than 165).
- Conditions
- Mitral Valve Insufficiency
- Being tested
- DragonFly Transcatheter Mitral 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.
DragonFly Transcatheter Mitral Valve Repair SystemDevice
Also called Transcatheter Mitral Valve repair (TMVr)
Edge-to-edge repair with DragonFly System
| Study group | Role | What they receive |
|---|---|---|
| DragonFly Transcatheter Mitral Valve Repair System-DMR | Experimental | Transcatheter mitral valve repair with the DragonFly System in patients with degenerative mitral regurgitation Receives: Device: DragonFly Transcatheter Mitral Valve Repair System |
| DragonFly Transcatheter Mitral Valve Repair System-FMR | Experimental | Transcatheter mitral valve repair with the DragonFly System in patients with functional mitral regurgitation Receives: Device: DragonFly Transcatheter Mitral Valve Repair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success at 12 months after the procedure for DMR Cohort only
The rate of the composite endpoint of freedom from all-cause mortality, surgery for mitral valve dysfunction, or MR > 2+ at 12 months.
Measured: 12 months
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
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 posted3 Jul 2023
- Study start1 Jan 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Valgen Medtech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Responsible party
- Sponsor
- Investigators
- Francesco Maisano, Principal investigator, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927441
- Sponsor's protocol ID
- DJ/TD/08CC-01E
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2023
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation Study of DragonFly System for Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05927441
- Acronym / sponsor ID
- DJ/TD/08CC-01E
- Conditions
- Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Hangzhou Valgen Medtech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Donawa Lifescience Consulting S.r.l.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 3 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 confirm the effectiveness and safety of the DragonFly Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Detailed description
This is a prospective, multicentric clinical investigation.
Subjects to be included in this clinical investigation suffer from symptomatic chronic moderate-to-severe (3+) or severe (4+) DMR with high or prohibitive surgical risk judged by a local investigation site's heart team and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Local heart teams must include at a minimum a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease. After signing the informed consent form (ICF), a subject will be enrolled and treated with the DragonFlyTM Transcatheter Mitral Valve Repair System (Valgen Medtech, Hangzhou).
The CE-DMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. Group sequential design analysis is planned based on an adaptive design to assess whether the primary endpoint will be met. If the primary endpoint is not met at the interim analysis, then it will be re-analyzed for 160 patients when all subjects in Europe/Canada complete 12 months follow-up.
The CE-FMR cohort clinical investigation will be assessed at the following intervals: implant, before discharge, 30 days, 6 months and annually for 5 years. An adaptive design with sample size re-estimation will be incorporated. The primary endpoint will be assessed at the interim analysis. If the conditional power falls within the promising zone (38-80%), then the sample size will be re-estimated to maintain at least 80% power. Then the primary endpoint will be evaluated once the 12-month follow-up is completed with the larger sample size (not less than 165).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DragonFly Transcatheter Mitral Valve Repair System-DMR | Experimental | Device: DragonFly Transcatheter Mitral Valve Repair SystemTranscatheter mitral valve repair with the DragonFly System in patients with degenerative mitral regurgitation |
| DragonFly Transcatheter Mitral Valve Repair System-FMR | Experimental | Device: DragonFly Transcatheter Mitral Valve Repair SystemTranscatheter mitral valve repair with the DragonFly System in patients with functional mitral regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years old
- New York Heart Association (NYHA) Class II-IV
- Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography (For DMR cohort)
- Symptomatic FMR ≥ 3+ due to ischemic or non-ischemic cardiomyopathy (For FMR cohort)
- Transseptal catheterization and femoral vein access are determined to be feasible
Key exclusion criteria (18 listed)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Other severe heart valve diseases requiring intervention
- Prior mitral valve leaflet surgery (prior annuloplasty ring not excluded) or previous transcatheter mitral valve intervention
- Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization
- Any cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to the procedure; or in the judgment of the investigator, the femoral vein cannot accommodate a 25 F catheter or the presence of an inferior vena cava filter would interfere with advancement of the catheter or ipsilateral deep vein thrombosis is present; or the patient's anatomy is not suitable for atrial septal puncture
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 Transcatheter Mitral Valve Repair SystemAlso: Transcatheter Mitral Valve repair (TMVr)Edge-to-edge repair with DragonFly System | Device | DragonFly Transcatheter Mitral Valve Repair System-DMR, DragonFly Transcatheter Mitral Valve Repair System-FMR |
Primary outcome
Treatment success at 12 months after the procedure for DMR Cohort only
Time frame: 12 months
The rate of the composite endpoint of freedom from all-cause mortality, surgery for mitral valve dysfunction, or MR > 2+ at 12 months.
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
Time frame: 12 months
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- 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.
Francesco Maisano principal investigator
Ospedale San Raffaele
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 Transcatheter Mitral Valve Repair System in people with Mitral Valve Insufficiency, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in Germany.
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 18 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuangjie Li (+8617756106609, shuangjie.li@valgenmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success at 12 months after the procedure for DMR Cohort only (time frame: 12 months). 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?
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 24 Nov 2025.