DragonFly EU Pivotal Study

NCT05927441 | Recruiting

• 1 other identifier: DJ/TD/08CC-01E
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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 regurgitation subjects who remained clinically symptomatic after adequate treatment.

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  12 months

Study Arms (2)

DragonFly Transcatheter Mitral Valve Repair System-DMR

EXPERIMENTAL

Transcatheter mitral valve repair with the DragonFly System in patients with degenerative mitral regurgitation

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

Device: DragonFly Transcatheter Mitral Valve Repair System

Interventions

DragonFly Transcatheter Mitral Valve Repair System DEVICE

Edge-to-edge repair with DragonFly System

Also known as: Transcatheter Mitral Valve repair (TMVr)

DragonFly Transcatheter Mitral Valve Repair System-DMR; DragonFly Transcatheter Mitral Valve Repair System-FMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead
• Donawa Lifescience: collaborator

Study Sites (1)

Universitatsklinikum Bonn Medizinische Klinik und Poliklinik

Bonn, Germany

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Maisano

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuangjie Li

CONTACT

+8617756106609; shuangjie.li@valgenmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: July 3, 2023
• Study Start: January 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)