A randomized controlled trial investigating the DragonFly System for the treatment of functional mitral regurgitation is set to begin recruitment. The trial, sponsored by Hangzhou Valgen Medtech Co., Ltd, marks a notable advancement in exploring device-based interventions for cardiovascular conditions.
What is the purpose of this trial?
The primary aim of this clinical trial is to evaluate the efficacy and safety of the DragonFly System, a medical device designed for the treatment of functional mitral regurgitation (FMR). Functional mitral regurgitation occurs when the mitral valve does not close properly due to changes in heart structure, leading to blood flow abnormalities and other associated risks. The DragonFly System offers a potential device-based solution, differentiating it from traditional pharmacological approaches.
What interventions will be evaluated?
This study will test two key interventions:
- Device: The DragonFly System, a novel technology aimed at mitigating the effects of mitral regurgitation.
- Drug: The trial will also include a pharmaceutical arm for comparison, assessing its role alongside the device in improving patient outcomes.
These interventions will contribute to assessing both standalone and combined efficacy in managing FMR. Collecting data will help clarify the specific therapeutic roles of each intervention.
Who is sponsoring this research?
The study is sponsored by Hangzhou Valgen Medtech Co., Ltd, a company focused on developing medical technology solutions. Their sponsorship underscores their commitment to addressing structural heart conditions through innovative device design and rigorous clinical studies. This focus aligns with global medical device regulatory principles prioritizing safety, performance, and clinical benefit.
Frequently Asked Questions
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What is functional mitral regurgitation?
Functional mitral regurgitation is caused by changes in the heart's structure, preventing the mitral valve from closing properly and resulting in blood leakage.
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What is the DragonFly System?
The DragonFly System is a device developed to address functional mitral regurgitation by improving the performance of the mitral valve.
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Is this trial currently recruiting?
No, according to the latest update, participant recruitment has not yet commenced.
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Who is conducting this trial?
The trial is being sponsored and conducted by Hangzhou Valgen Medtech Co., Ltd, a medical technology company.
Conclusion and Next Steps
The DragonFly System trial reflects a growing interest in leveraging device-based solutions for functional mitral regurgitation. By directly addressing unmet clinical needs, the study has the potential to reshape treatment paradigms. Stakeholders in the medical device industry should maintain focus on its developments. Regulatory teams may benefit from examining this study’s design and compliance with clinical trial guidance.
Disclaimer
This article is intended for clinical, quality, and regulatory professionals only. It does not constitute legal or medical advice. Consult relevant guidelines and legal counsel for specific requirements.
Announcement Line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07243158?term=medical+device