The TRICURE US IDE Pivotal Study
ConditionTricuspid Regurgitation (TR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRiCares
About this trial
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient is ≥ 18 years of age
Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team
Disqualifiers
Patient has a tricuspid device currently in place
Patient has anatomical contraindications
Patient is in need of urgent surgery
Patient has a left ventricular ejection fraction of < 25%
Trial design
Design model
Parallel
Treatments tested in this trial
TRiCares Topaz TTVR System
DeviceTRiCares Topaz TTVR System
Edwards EVOQUE TTVR System
DeviceEdwards EVOQUE TTVR System
TRiCares Topaz TTVR System
DeviceTRiCares Topaz TTVR System
Treatment groups
831 Participants
are divided into 3 treatment groupsGroup A: TRiCares Topaz TTVRExperimental treatment 1 intervention
Group B: Edwards EVOQUE TTVRActive comparator 1 intervention
Group C: Single Arm RegistryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Major Adverse Events (MAE)
Time frame
30 days post-procedure2
Composite Endpoint
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
Time frame
1 year post-procedureSecondary outcomes
1
Change in qualify of life (QoL)
as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time frame
1 year post-procedureLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: