Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
Recruiting
N/A
Interventional Study
Tricuspid Regurgitation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 236 (estimated)
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd · Industry
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About This Trial
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.
3. Despite the drug optimization treatment according to the above met…
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