Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation

NCT04733404 | Recruiting

• 1 other identifier: DragonFly-02
• Study Type: interventional
• Target: 120
• 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 chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.

Conditions

Mitral Regurgitation Functional

Outcome Measures

Primary Outcomes (1)

• Number of patients with composite measures- All-cause death and recurrent HF hospitalizations.

  A composite of all-cause death or recurrent heart failure (HF) hospitalizations.

  12 months

Secondary Outcomes (8)

• Mitral regurgitation severity

  30 days, 6 months, 12 months

• Recurrent heart failure (HF) hospitalizations

  30 days, 6 months, 12 months

• NYHA Class

  30 days, 6 months, and 12 months

• Change in 6 minutes walk test distance

  12 months

• Quality of life improvement

  12 months

Other Outcomes (3)

• Incidence of major adverse events (MAEs)

  30 days, and 12 months

• All-cause mortality

  30 days, 6 months, and 12 months

• Cardiac mortality

  30 days, 6 months, and 12 months

Study Arms (1)

Dragonfly Mitral Valve Repair System

EXPERIMENTAL

The experimental group is allocated to use a novel mitral valve repair system for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.

Device: Dragonfly Transcatheter Mitral Valve Repair System

Interventions

Dragonfly Transcatheter Mitral Valve Repair System DEVICE

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

Dragonfly Mitral Valve Repair System

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 yrs.
• 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:
• GDMT dose increase of no greater than 100% or decrease of no greater than 50%.
• 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%).
• 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.
• NYHA functional class II to IVa.
• Left ventricular ejection fraction (LVEF) ≥ 20% and ≤50%.
• Left ventricular end-systolic dimension (LVESD) ≤ 70 mm.
• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique and can be treated by the DragonflyTM device.
• Elevated BNP \>150 pg/ml or corrected NT-proBNP ≥600 pg/ml or heart failure hospitalization within the past 12 months ('corrected' refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).
• 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.

You may not qualify if:

• Echocardiographic evidence of intracardiac 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.
• 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.
• Moderate to severe right heart dysfunction or an estimated pulmonary artery systolic pressure (PASP) \> 70 mmHg 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 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.
• 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.
• 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 heart transplantation.
• Active endocarditis, or active rheumatic heart disease, or leaflets degenerated from either endocarditis or rheumatic disease.
• Severe Chronic Obstructive Pulmonary Disease (COPD) (requiring continuous home oxygen therapy or long-term application of steroid hormone medication).
• Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (\> 70% by ultrasound), or carotid artery stenting within 30 days.
• Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.
• Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication.

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Study Officials

• Jianan Wang, MD, PH.D

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Dai

CONTACT

+8617710418660; jing.dai@valgenmed.com

Shuangjie Li

CONTACT

+8617756106609; shuangjie.li@valgenmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: March 12, 2022
• Primary Completion: September 30, 2023
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 29, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)