DragonFly M2 Pivotal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DragonFly M2 Transcatheter Mitral Valve Repair System.
- Who it may be relevant to
- Registry conditions: Mitral Valve (MV) Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Performance Evaluation Study of DragonFly M2 System for Mitral Regurgitation
Overview
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.
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.
Interventions
- Device DragonFly M2 Transcatheter Mitral Valve Repair System
Edge-to-edge repair with DragonFly M2 System
Primary outcome measures
- Procedure success [Time frame: 30 Days]
Secondary outcome measures (5)
- Single-click release success [Time frame: Intraoperative]
- Acute device success [Time frame: Immediately after procedure]
- surgical intervention [Time frame: 30 days, 6 months, and 12 months]
- NYHA Class [Time frame: 30 days, 6 months, and 12 months]
- Quality of life improvement [Time frame: 30 days, 6 months, and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fuwai Hospital Chinese Academy of Medical Sciences — Shenzhen
Identifiers
NCT: NCT07243197 · DragonFly-M2 01