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 system) to Control (Medical Therapy).
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Efficacy of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation. After signing the informed consent form, participants in the experimental group will be treated with the Dejin Medical DragonFly-T Transcatheter Tricuspid Valve Clip System and continue receiving medical therapy as determined by the investigator. Participants in the control group will continue to receive medical therapy as determined by the investigator. Control group participants are allowed to cross over to the experimental group after completing the 12-month follow-up. All participants will undergo clinical follow-up before discharge (not applicable to control group participants), at 30 days post-treatment, 6 months post-treatment, 12 months post-treatment, and annually at 2, 3, 4, and 5 years.. The primary endpoint is the hierarchical composite endpoint formed by all-cause mortality or tricuspid valve reintervention, heart failure hospitalization, and KCCQ improvement at 12 months post-treatment. To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
Subjects will continue to be managed on medical therapy, per physician discretion
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGHierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement
Time frame: 12 months
Tricuspid regurgitation severity
Percentage of patients with tricuspid regurgitation of 2+ or less.
Time frame: 30 days, 6 months, and 12 months
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance
Time frame: 30 days, 6 months, and 12 months
Quality of life improvement
Improvement in quality of life (QoL) , as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Time frame: 30 days, 6 months, and 12 months
Acute procedural success
Time frame: Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory
Acute device success
Time frame: Immediately after procedure
Incidence of major adverse events (MAEs)
Time frame: 30 days
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