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%
Single group
VDyne Transcatheter Tricuspid Valve Replacement System
DeviceThe study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE)
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 as measured by the Imaging Core Labs
Change in tricuspid valve regurgitation as measured by the Imaging Core Labs
Changes in quality of life as measured by the KCCQ changes.
Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome.
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)
The percentage of subjects with Device- and/or Procedure related Major Adverse Events as classified by the CEC
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Change in tricuspid valve regurgitation as measured by the Imaging Core Lab
Intra-Procedural success
Rate of successful implantation of the VDyne Valve using the VDyne Delivery System, absence of procedural mortality or stroke, adequate performance of the VDyne Valve, no device-related obstruction of forward flow or pulmonary embolism and \& freedom from emergency surgery or reintervention during the first 24 hours related to the device or access procedure.
Clinical success
Absence of procedural mortality, proper position of the device with adequate performance, freedom from unplanned surgical or interventional procedures related to the device or procedure, absence of major adverse events, device related pulmonary embolism and obstruction of forward flow, any severe hemodynamic compromise leading to heart transplantation or major cardiac assistance or any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
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