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Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation | Clinical Trials | Clareo Health

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Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation

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

NCT04733404•Hangzhou Valgen Medtech Co., Ltd

View on ClinicalTrials.gov

Summary

To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.

Detailed Description

This study is a prospective, multicenter, objective performance criteria design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. 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 procedure, before discharge, 30 days after procedure, 6 months after procedure, and 12 months after procedure. The primary outcome is defined as a composite measure include all-cause mortality and recurrent heart failure hospitalization at 12 months after procedure. The secondary outcomes include acute procedural success, acute device success, mitral regurgitation degree (MR≤2+), recurrent heart failure hospitalization, NYHA class I or II at 30 days, 6 months, and 12 months, and the improvement in 6 minutes walk test distance, left ventricular end-diastolic volume, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline at 12 months after procedure. The safety endpoints include major adverse events (MAEs) at 30 days and 12 months after procedure, and all-cause mortality, cardiac mortality at 30 days, 6 months, and 12 months after procedure. To evaluate the safety and effectiveness of the Valgen Medtech DragonFly Transcatheter Mitral Valve Repair System in the treatment of patients with chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment, and to evaluate the product performance.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥ 18 yrs.
•2. Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.
•Note 2: An Eligible transthoracic echocardiography must be obtained at least 30 days after the subject has been stabilized on optimal therapy with Guideline Directed Medical Therapy (GDMT), and after meeting two of the following conditions:
•1. GDMT dose increase of no greater than 100% or decrease of no greater than 50%.
•2. Coronary revascularization and/or implantation of a cardiac resynchronization therapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-D resulting in an increase in biventricular pacing (from \<92% to ≥92%).
•3. Subjects have been adequately treated according to applicable criteria, including treatment for coronary artery disease, left ventricular dysfunction, mitral regurgitation, and heart failure (e.g., with cardiac resynchronization therapy (CRT or CRT-D), coronary revascularization, and/or have received stable GDMT, as defined in (Appendix IV: Definition of GDMT), confirmed by the local heart team.
•4. NYHA functional class II to IVa.
•5. Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.
•6. Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.
•7. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the DragonflyTM device.
+3 more criteria

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.
•4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
•5. Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \> 70 mmHg assessed by echocardiography.
•6. History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization.
•7. Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization, or any implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) or Implantable Cardioverter Defibrillator (ICD) within the last 30days prior to subject registration.
•8. 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.
•9. Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated.
•10. End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation, or on the waiting list for heart transplantation.
+12 more criteria

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 12, 2022

Primary Completion Date

September 30, 2023

Completion Date

September 30, 2027

Last Updated

March 29, 2022

Enrollment

120

ESTIMATED participants

Conditions

Mitral Regurgitation Functional

Interventions

Dragonfly Transcatheter Mitral Valve Repair System

DEVICE

Contacts

Jing Dai

CONTACT

+8617710418660 jing.dai@valgenmed.com

Shuangjie Li

CONTACT

+8617756106609 shuangjie.li@valgenmed.com

Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation

NCT07243158

Mitral Regurgitation Functional

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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