Tricuspid Regurgitation, Tricuspid Valve Disease, Tricuspid Valvular Disorders
Conditions
Brief summary
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.
Interventions
The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System.
Sponsors
VDyne, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe or greater tricuspid valve regurgitation of primary or secondary etiology. 2. NYHA class ≥ II. If NYHA Class IV, patient must be ambulatory. 3. Subject is adequately treated with medical therapy for heart failure \>30 days prior to index procedure, including a diuretic. 4. Heart Team determines patient is a recommended candidate for the VDyne System. 5. Age 18 years or older at time of the index procedure. 6. Clinical Screening Committee (CSC) and Imaging Core Labs confirm suitability for treatment with the VDyne System.
Exclusion criteria
VDYNE SYSTEM SUITABILITY 1. 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) 2. Intolerance to procedural anticoagulation or post-procedural antiplatelet/anticoagulation regimen that cannot be medically managed 3. Hypersensitivity to nickel or titanium CLINICAL
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) | 30 days post-procedure | 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 | From Baseline to 1 month post-procedure | Change in tricuspid valve regurgitation as measured by the Imaging Core Labs |
| Changes in quality of life as measured by the KCCQ changes. | From Baseline to 1 month post-procedure | Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome. |
| Changes in functional capacity (6-minute walk test) | From Baseline to 1 month post-procedure | Changes in functional capacity (6-minute walk test) |
| Changes in symptom status (NYHA class) | From Baseline to 1 month post-procedure | Changes in symptom status (NYHA class) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of subjects with Device- and/or Procedure-related Major Adverse Events (MAE) | From Baseline to 1 year post-procedure | 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 | From Baseline to 3 months, 6 months and 1 year | Change in tricuspid valve regurgitation as measured by the Imaging Core Lab |
| Intra-Procedural success | From implant start time to procedure room exit | 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 | From implant to 30 days post implant | 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. |
| Changes in symptom status (NYHA class) | From Baseline to 3 months, 6 months and 1 year | Changes in symptom status (NYHA class) |
| Changes in functional capacity (6 minute walk test) | From Baseline to 3 months, 6 months and 1 year | Changes in functional capacity (6 minute walk test) |
| Changes in quality of life as measured by the KCCQ changes. | From Baseline to 3 months, 6 months and 1 year | Changes in quality of life as measured by the KCCQ changes. Higher score indicates worse outcome. |
Countries
Australia, Austria, Belgium, Czechia, Denmark, Germany, Netherlands, New Zealand, Spain, Sweden, United Kingdom
Contacts
CONTACTVinny Podichetty
CONTACTPree Bassi
STUDY_DIRECTORVinny Podichetty
VDyne, Inc.
Outcome results
None listed