Cardiovascular Diseases, Heart Valve Disease, Tricuspid Valve Regurgitation
Conditions
Brief summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Detailed description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Interventions
Replacement of the tricuspid valve through a transcatheter approach
Sponsors
TRiCares
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
* Adult patients * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential) * Institutional Heart Team evaluates patient as being at increased operative risk
Exclusion criteria
* Patient in need of emergent intervention * Patient who is hemodynamically unstable * Anatomical contraindications for implantation with study device * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of MAE | 30 day post-intervention | Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications. |
| Investigational Device Success | immediately post-intervention | Device success defined as a reduction in tricuspid regurgitation immediately post-intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Six minute walk test | 30 days, 6 months, annual for five years post-intervention | Change in distance (m) compared to baseline assessment |
| Reduction in Tricuspid Regurgitation (TR) Grade | 30 days, 6 months, annual for five years post-intervention | Number of patients presenting with reduction in TR grade compared to baseline assessment |
| New York Heart Association (NYHA) Function Class | 30 days, 6 months, annual for five years post-intervention | Number of patients presenting with improvement in NYHA classification |
Countries
Belgium, Germany
Contacts
CONTACTEsther Gerteis
PRINCIPAL_INVESTIGATORJörg Hausleiter, MD
LMU Munich
Outcome results
None listed