Status:
RECRUITING
Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)
Lead Sponsor:
Edwards Lifesciences
Conditions:
Tricuspid Valve Regurgitation
Heart Valve Diseases
Eligibility:
All Genders
Brief Summary
This is a prospective, single-arm, multi-center, real-world study of an the Edwards EVOQUE system.
Detailed Description
This is a prospective, single-arm, multi-center, real-world study of an approved device. Up to 500 patients will be enrolled in this study at up to 45 sites in Europe. All enrolled patients will be as...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2033
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06569602
Start Date
October 1 2024
End Date
September 30 2033
Last Update
October 31 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Herz-und Diabeteszentrum NRW
Bad Oeynhausen, Germany
2
Inselspital
Bern, Switzerland