DragonFly M2 Pivotal Study

ConditionMitral Valve (MV) Regurgitation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorHangzhou Valgen Medtech Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

DragonFly M2 Transcatheter Mitral Valve Repair System
Device
Edge-to-edge repair with DragonFly M2 System

Treatment groups

53 Participants

are divided into 1 treatment group

Group A: DragonFly M2 Transcatheter Mitral Valve Repair SystemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

30 Days

Secondary outcomes

Single-click release success

successful clip detachment from the delivery system at the intended position during the first release attempt

Time frame

Intraoperative

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.

Time frame

Immediately after procedure

surgical intervention

surgical interventions due to post-procedural mitral valve dysfunction

Time frame

30 days, 6 months, and 12 months

NYHA Class

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

Time frame

30 days, 6 months, and 12 months

Other outcomes

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.

Time frame

30 days, 6 months, and 12 months

All-cause mortality

Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.

Time frame

30 days, 6 months, and 12 months

Cardiovascular death

Time frame

30 Days, 6 months, 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Valgen Medtech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: