Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorEdwards Lifesciences
About this trial
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Eligibility criteria
Qualifiers
The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement with the EVOQUE system per the current instructions for use.
Patient agrees to attend follow-up assessments.
Patients provided written informed consent for participation in the study.
Disqualifiers
Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
Any patient considered to be part of a vulnerable population.
Trial design
Treatments tested in this trial
- Transcatheter Tricuspid Valve Replacement
Treatment groups
500 Participants
are divided into 1 treatment groupLocations
2Germany
Herz-und Diabeteszentrum NRW Bad Oeynhausen Germany
Switzerland
Inselspital Bern Switzerland
Sponsors and collaborators
Edwards Lifesciences
Lead sponsor
Source ClinicalTrials.gov