Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation - Trial NCT05671640

Timeline & Enrollment

Primary Outcome

Incidence of major adverse events (MAEs)

Summary

This study is a prospective design. Patients are severe tricuspid regurgitation (TR) (≥ 3+)
 who remained clinically symptomatic after guideline-directed medical treatment. After signing
 an informed consent form, subjects are enrolled and treated with the DragonFly-T
 Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up
 immediately after the procedure, before discharge, 30 days after the procedure, 6 months
 after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure.
 
 The incidence of MAEs (Major Adverse Events) at 30 days is used as the safety endpoint. The
 MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery,
 and non-elective cardiovascular interventions due to device-related adverse events.
 
 The efficacy endpoints include acute procedural success, acute device success, the incidence
 of all-cause mortality and/or heart failure rehospitalization at 12 months after the
 procedure, the percentage of patients with tricuspid regurgitation of 2+ or less, the
 percentage of patients with tricuspid regurgitation reduced by at least one grade, the
 improvement in 6 minutes walk test, New York Heart Association (NYHA) class, quality of life
 change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and change in
 edema scale grading.

ICD-10 Classifications