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Degenerative Mitral Valve DiseaseNCT04734756

Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation

A study testing Dragonfly Transcatheter Mitral Valve Repair System in people with Degenerative Mitral Valve Disease, run by Hangzhou Valgen Medtech Co., Ltd at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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 (DMR) in high surgical risk subjects. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Degenerative Mitral Valve Disease
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
120 participants
Where
1 siteChina
Study dates
4 May 2021to 31 May 2027
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

  • Age ≥ 18 yrs.
  • Symptomatic moderate-to-severe (3+) or severe (4+) mitral valve regurgitation (DMR) confirmed by transthoracic echocardiography.
  • NYHA functional class II, III, IV.
  • Left ventricular ejection fraction (LVEF) ≥ 20%.
  • Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique, and can be treated by the DragonflyTM device, as assessed by the site investigators and confirmed by the echo core laboratory and eligibility committee.
  • High 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; or other high surgical risks. e.g. presence of ≥2 moderate to severe frailty factors; or the presence of possible surgical obstacles; or the presence of ≥2 major organ dysfunctions that could not be improved after surgery; or other surgical high-risk factors as determined by the local heart team.
  • Transseptal catheterization and femoral vein access is determined to be feasible.
  • The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.

Who cannot join

  • Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation.
  • The presence of other severe heart valve disease requiring surgical intervention.
  • Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.
  • Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by echocardiography.
  • History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization.
  • Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization; or if, in the judgment of the investigator, the subject's femoral vein is unable to accommodate a 25F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture.
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  • Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated.
  • End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation, or on the waiting list for a heart transplantation.
  • Active endocarditis, or active rheumatic heart disease, or leaflets degenerated from either endocarditis or rheumatic disease.
  • Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (> 70% by ultrasound).
  • Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.
  • Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication.
  • Modified Rankin Scale ≥4.
  • The subjects suffer from diseases which may lead difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.);
  • Pregnant or breastfeeding women.
  • Hemodynamic instability defined as systolic pressure < 90 mmHg without afterload reduction, cardiogenic shock, or the need for inotropic support or an intra-aortic balloon pump.
  • Active infections requiring antibiotic therapy (in the case of temporary illness, antibiotics must be discontinued for at least 14 days before the subject can be enrolled).
  • Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  • In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit 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.

China1 site

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

Official title: A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Degenerative Mitral Regurgitation (DMR) Subjects.

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 (DMR) in high surgical risk subjects.

Read the detailed description

This study is a prospective, multicenter, objective performance criteria design. Patients are clinically symptomatic patients with chronic moderate to severe (3+) or severe (4+) organic mitral regurgitation (DMR) who were assessed as high risk for surgical procedures by the cardiac team at the local clinical trial site. After signing an informed consent form, subjects are enrolled and treated with the DragonFly Transcatheter Mitral Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, and 30 days, 6 months, and 12 months after the procedure.

Treatment success at 12 months is used as the primary endpoint, with the definition as freedom from death, valve dysfunction surgery, and moderately severe or severe mitral regurgitation (MR >2+) at 12 months.

The secondary endpoints include acute procedural success, acute device success, and surgery for valve dysfunction, NYHA class I or II at 30 days, 6 months, and 12 months, and the improvement in the quality of life change from baseline as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months after the procedure. The safety endpoints include major adverse events (MAEs), all-cause mortality, and cardiac mortality at 30 days, 6 months, and 12 months after the procedure.

To evaluate the safety and effectiveness of the Valgen Medtech DragonFly Transcatheter Mitral Valve Repair System in the treatment of patients with clinically significant chronic moderate (3+) or severe (4+) degenerative mitral regurgitation (DMR) who have been evaluated by the local heart team as being at high surgical risk, and to evaluate the product performance.

Being tested
Dragonfly Transcatheter Mitral Valve Repair System

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

    To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.

Study groups in NCT04734756
Study groupRoleWhat they receive
Dragonfly Mitral Valve Repair SystemExperimentalThe experimental group is allocated to use a novel mitral valve repair system for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
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.

  1. Treatment success

    Percentage of patients freedom from: death, surgery for valve dysfunction, and MR > 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .

    Measured: 12 months

Secondary outcomes (5)

  1. Acute procedural success

    Successful in Dragonfly implantation, and residual MR of 2+ or less at discharge. An echocardiography 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: Immediately after procedure, Discharge: 1 day after the patient's exit from the cardiac catheterization laboratory

  2. Acute device success

    One or more Dragonfly devices are successfully delivered and released, edge-to-edge leaflet repair confirmed by echocardiogram, and successfully withdrawal of the delivery catheter.

    Measured: Immediately after procedure

  3. Composite of function and re-operation measures

    Number of patients freedom from postoperative surgery for mitral valve dysfunction.

    Measured: 30 days, 6 months, and 12 months

  4. NYHA Class

    Number of patients with New York Heart Association (NYHA) Function Class I or II.

    Measured: 30 days, 6 months, and 12 months

  5. Quality of life improvement

    Improvement in quality of life (QoL) at 12 months over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start4 May 2021
  3. Primary completion31 May 2023 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04734756
Sponsor's protocol ID
DragonFly-01
Status last verified
Jun 2021
First submitted
27 Jan 2021
Last updated
11 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lin X, Tan B, Li C, Liang J, Yan H, Zhu Q, Liu X. Prognostic Value of Prolapse Width for Mid-Term Degenerative Mitral Regurgitation Stability After Transcatheter Edge-to-Edge Repair. Echocardiography. 2026 Aug;43(8):e70596. doi: 10.1111/echo.70596.

    PubMed 42579324

  • Wang J, Liu X, Pu Z, Chen M, Fang Z, Jin J, Dong J, Guo Y, Cheng B, Xiu J, Luo J, Tang Y, Wang Y, Chen X, Zhang G, Shao Y, Song G, Hong L, Jiang H, Wu Y, Yuan Y, Chen L, He B, Wang J, Xu K, Yang Y, Zhou D, Zhang Q, Li Y, Ma K, Lam YY, Han Y, Ge J, Lim DS, Pivotal Trial Investigators FTD. Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial. EuroIntervention. 2024 Feb 19;20(4):e239-e249. doi: 10.4244/EIJ-D-23-00361.

    PubMed 38389469

Questions about this trial

What is this clinical trial studying?

A study testing Dragonfly Transcatheter Mitral Valve Repair System in people with Degenerative Mitral Valve Disease, 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 19 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: enrolling by invitation, as of the sponsor's last update on 11 Jun 2021. 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?

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?

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 success (time frame: 12 months). 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 NCT04734756, which also lists 2 linked publications.

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 11 Jun 2021; AzTrials last refreshed its copy on 26 Oct 2026.

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