DragonFly M2 Pivotal Study

Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation

To confirm the effectiveness and safety of the DragonFly M2 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.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Valve (MV) Regurgitation
• Intervention / Treatment: Device: DragonFly M2 Transcatheter Mitral Valve Repair System

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 .

After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly M2 Transcatheter Mitral Valve Clip System. All subjects were followed up immediately after procedure, before discharge, 30 days , 6 months, 12 months after procedure, and 2, 3, 4, and 5 years after procedure.

• Study Type: Interventional
• Enrollment (Estimated): 53
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bo Liu; Phone Number: +86 13001980902; Email: bo.liu@valgenmed.com
• Study Contact Backup: Name: Xiaoxu Yang; Phone Number: +8618910330079; Email: xiaoxu.yang@valgenmed.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518000
      • Fuwai Hospital Chinese Academy of Medical Sciences
      • Contact: Xiangbin Pan, MD, PH.D; Phone Number: +8618010155168

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1.≥ 18 years old. 2.Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography.

• Transseptal catheterization is determined to be feasible by the Investigator.
• Patients 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.

Exclusion Criteria:

1)Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2) The presence of other severe heart valve disease requiring surgical intervention.

3) Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DragonFly M2 Transcatheter Mitral Valve Repair System; Transcatheter mitral valve repair with the DragonFly M2 System in patients with degenerative mitral regurgitation	Device: DragonFly M2 Transcatheter Mitral Valve Repair System; Edge-to-edge repair with DragonFly M2 System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success	Procedure success: device implanted successfully, MR ≤ 2+ at discharge (or 30-day echo if unavailable), and no death or device-related reintervention within 30 days post-procedure.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA Class	Number of patients with New York Heart Association (NYHA) Function Class I or II.	30 days, 6 months, and 12 months
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.	Immediately after procedure
Single-click release success	successful clip detachment from the delivery system at the intended position during the first release attempt	Intraoperative
surgical intervention	surgical interventions due to post-procedural mitral valve dysfunction	30 days, 6 months, and 12 months
Quality of life improvement	Improvement in quality of life (QoL) over baseline, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).	30 days, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.	30 days, 6 months, and 12 months
Incidence of major adverse events (MAEs)	MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, renal failure, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.	30 days, 6 months, and 12 months
Cardiovascular death	Cardiovascular death	30 Days, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Hangzhou Valgen Medtech Co., Ltd
• Investigators: Principal Investigator: Xiangbin Pan, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux
• Other Study ID Numbers: DragonFly-M2 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No