Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation

NCT04734756 | Enrolling By Invitation

• 1 other identifier: DragonFly-01
• 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 symptomatic moderate-to-severe(3+) or severe(4+) degenerative mitral regurgitation (DMR) in high surgical risk subjects.

Conditions

Degenerative Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Treatment success

  Percentage of patients freedom from: death, surgery for valve dysfunction, and MR \> 2+ (moderate to severe (3+) or severe (4+) mitral regurgitation) .

  12 months

Secondary Outcomes (5)

• Acute procedural success

  Immediately after procedure, Discharge: 1 day after the patient's exit from the cardiac catheterization laboratory

• Acute device success

  Immediately after procedure

• Composite of function and re-operation measures

  30 days, 6 months, and 12 months

• NYHA Class

  30 days, 6 months, and 12 months

• Quality of life improvement

  12 months

Other Outcomes (3)

• Incidence of major adverse events (MAEs)

  30 days, 6 months, 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 moderate-to-severe (3+) or severe (4+) mitral valve regurgitation (DMR) confirmed by transthoracic echocardiography.
• NYHA functional class II, III, IV.
• Left ventricular ejection fraction (LVEF) ≥ 20%.
• Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique, and can be treated by the DragonflyTM device, as assessed by the site investigators and confirmed by the echo core laboratory and eligibility committee.
• High surgical risk as defined by either Society for Thoracic Surgery Risk Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points; or other high surgical risks. e.g. presence of ≥2 moderate to severe frailty factors; or the presence of possible surgical obstacles; or the presence of ≥2 major organ dysfunctions that could not be improved after surgery; or other surgical high-risk factors as determined by the local heart team.
• 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 intra-cardiac 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.
• Estimated pulmonary artery systolic pressure (PASP) \> 70 mm Hg 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 if, 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 a heart transplantation.
• Active endocarditis, or active rheumatic heart disease, or leaflets degenerated from either endocarditis or rheumatic disease.
• Cerebrovascular accident within 30 days prior to randomization or symptomatic severe carotid stenosis (\> 70% by ultrasound).
• Evidence of acute peptic ulcer or gastrointestinal hemorrhage in the prior 3 months.
• Hemorrhagic or coagulopathic disorders, contraindications to antithrombotic medication.
• Modified Rankin Scale ≥4.
• The subjects suffer from diseases which may lead difficulty in evaluating treatment (e.g., cancer, severe metabolic disease, psychosis, etc.);
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Hangzhou Valgen Medtech Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Wang J, Liu X, Pu Z, Chen M, Fang Z, Jin J, Dong J, Guo Y, Cheng B, Xiu J, Luo J, Tang Y, Wang Y, Chen X, Zhang G, Shao Y, Song G, Hong L, Jiang H, Wu Y, Yuan Y, Chen L, He B, Wang J, Xu K, Yang Y, Zhou D, Zhang Q, Li Y, Ma K, Lam YY, Han Y, Ge J, Lim DS, Pivotal Trial Investigators FTD. Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial. EuroIntervention. 2024 Feb 19;20(4):e239-e249. doi: 10.4244/EIJ-D-23-00361.

  PMID: 38389469 DERIVED

Study Officials

• Jianan Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

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: May 4, 2021
• Primary Completion: May 31, 2023
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 11, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)