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

Launched by EDWARDS LIFESCIENCES · Aug 21, 2024

Keywords

ClinConnect Summary

The TRISCEND III EU trial is studying the safety and effectiveness of a new heart valve treatment called the Edwards EVOQUE system, specifically for patients with tricuspid valve regurgitation and other heart valve diseases. This trial is currently looking for participants across multiple centers in Europe. To be eligible, patients must be deemed suitable for this treatment by their local heart team and agree to follow-up visits after the procedure. Additionally, they need to provide written consent to participate.

If you join the trial, you will receive the EVOQUE system to help improve your heart function and reduce symptoms related to your condition. All genders and a wide age range of patients are welcome to participate, as long as they meet the inclusion criteria. It’s important to note that if you are already involved in another clinical study or are part of a vulnerable population, you may not be able to take part in this trial. Participants will be closely monitored to ensure their safety throughout the study.

Gender

ALL

Eligibility criteria

• 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.