The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
Severe or greater 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.
Heart Team determines patient is a recommended candidate for the VDyne System.
Patient anatomy (cardiac and vascular) is not suitable for the VDyne System as assessed by Imaging Core Labs, Sponsor and/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%
VDyne, Inc.
Lead sponsor