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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGIncidence of major adverse events (MAEs)
MAEs include stroke, cardiovascular death, new renal failure, endocarditis requiring surgery, and non-elective cardiovascular interventions due to device-related adverse events
Time frame: 30 days
Acute procedural success
Successful in DragonFly-T implantation, and residual TR of 2+ or less at discharge. An echocardiography echocardiogram at 30 days can be accepted if the discharge image was not available or hard to interpret. A death before discharge or a re-operation of tricuspid valve prior to 30 days is defined as acute procedure failure
Time frame: Immediately after procedure
Acute device success
One or more DragonFly-T devices are successfully delivered and released, edge-to-edge leaflet repair confirmed by echocardiogram, and successfully withdrawal of the delivery catheter
Time frame: Immediately after procedure
Incidence of all-cause mortality and/or heart failure rehospitalization
Incidence of all-cause mortality and/or heart failure rehospitalization
Time frame: 12 months
Tricuspid regurgitation severity
Percentage of patients with tricuspid regurgitation of 2+ or less
Time frame: 30 days, 6 months, 12 months
Tricuspid regurgitation severity change
Percentage of patients with tricuspid regurgitation reduced by at least one grade
Time frame: 30 days, 6 months, 12 months
Change in 6 Minutes Walk Test
Improvement in 6 Minute Walk Test
Time frame: 30 days, 6 months, 12 months
Change in NYHA class
Improvement in New York Heart Association (NYHA) Function Class
Time frame: 30 days, 6 months, 12 months
Quality of life improvement
Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire
Time frame: 30 days, 6 months, 12 months
Change in edema grading
Improvement in grading of edema,1-4 grade scale,higher scores mean worse outcome
Time frame: 30 days, 6 months, 12 months
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