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

Last updated: October 29, 2024
Sponsor: Edwards Lifesciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Treatment

Transcatheter Tricuspid Valve Replacement

Clinical Study ID

NCT06569602
2024-07
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The Local Site Heart Team determines that the patient is appropriate fortranscatheter tricuspid valve replacement with the EVOQUE system per the currentinstructions for use.

  2. Patient agrees to attend follow-up assessments.

  3. Patients provided written informed consent for participation in the study.

Exclusion

Exclusion Criteria:

  1. Patient participating in another interventional biologic, drug, or device clinicalstudy that has not met its primary endpoint(s).

  2. Any patient considered to be part of a vulnerable population.

Study Design

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: Transcatheter Tricuspid Valve Replacement
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
September 30, 2033

Study 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 assessed at the following intervals: baseline, index procedure, discharge (or 7-days post-index procedure whichever occurs first), 30 days, 1 year, and annually through 5 years.

Study enrollment is expected to last approximately 2-4 years, followed by 5 years of follow-up.

Connect with a study center

  • Herz-und Diabeteszentrum NRW

    Bad Oeynhausen,
    Germany

    Active - Recruiting

  • Inselspital

    Bern,
    Switzerland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.