Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Herz-und Diabeteszentrum NRW
RECRUITING
Bad Oeynhausen
Switzerland
Inselspital
NOT_YET_RECRUITING
Bern
Contact Information
Primary
TMTT Clinical
TMTT_Clinical@Edwards.com
+1-949-250-2500 or
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2033-09-30
Participants
Target number of participants: 500
Treatments
Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences