Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)

Summary

This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.

Eligibility

Inclusion Criteria:

1. 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.
2. Patient agrees to attend follow-up assessments.
3. Patients provided written informed consent for participation in the study.

Exclusion Criteria:

1. Patient participating in another interventional biologic, drug, or device clinical study that has not met its primary endpoint(s).
2. Any patient considered to be part of a vulnerable population.

Conditions4

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