The TRICURE EU Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRiCares
About this trial
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcatheter Tricuspid Valve Replacement
DeviceReplacement of the tricuspid valve through a transcatheter approach
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Transcatheter Tricuspid Valve ReplacementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite of MAE
Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Time frame
30 day post-intervention2
Investigational Device Success
Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
Time frame
immediately post-interventionSecondary outcomes
1
Six minute walk test
Change in distance (m) compared to baseline assessment
Time frame
30 days, 6 months, annual for five years post-intervention2
Reduction in Tricuspid Regurgitation (TR) Grade
Number of patients presenting with reduction in TR grade compared to baseline assessment
Time frame
30 days, 6 months, annual for five years post-intervention3
New York Heart Association (NYHA) Function Class
Number of patients presenting with improvement in NYHA classification
Time frame
30 days, 6 months, annual for five years post-intervention Source ClinicalTrials.gov