RecruitingNCT06569602
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Sponsor
Edwards Lifesciences
Enrollment
500 participants
Start Date
Oct 1, 2024
Study Type
OBSERVATIONAL
Conditions
Summary
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Eligibility
Inclusion Criteria3
- 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.
Exclusion Criteria2
- 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.
Interventions
DEVICETranscatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06569602
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