The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).
Symptomatic severe tricuspid valve regurgitation of primary or secondary etiology.
NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory.
Subject is adequately treated with medical therapy for heart failure ≥ 30 days prior to
index procedure, including a diuretic.
Patient anatomy (cardiac and vascular) is not suitable for VDyne System as assessed by Imaging Core Labs, Sponsor or Clinical Screening Committee (CSC)
Intolerance to procedural anticoagulation or post-procedural antiplatelet/ anticoagulation regimen that cannot be medically managed
Hypersensitivity to nickel or titanium
Left Ventricular Ejection Fraction (LVEF) <30%.
Single group
VDyne Transcatheter Tricuspid Valve Replacement System
DeviceThe study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) within 30 days of the procedure, as classified by the Clinical Events Committee (CEC).
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Changes in symptom status (NYHA class)
Changes in symptom status (NYHA class)
Changes in functional capacity (6-minute walk test)
Changes in functional capacity (6-minute walk test)
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC).
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) after 30 days to 1 year of the procedure, as classified by the Clinical Events Committee (CEC).
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation compared to baseline as measured by the Imaging Core Labs
Changes in right ventricle as measured by core lab
Changes in the right ventricle as measured by core lab
Rate of heart failure hospitalization
Rate of heart failure hospitalization
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