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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2033-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Treatment

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Transcatheter Tricuspid Valve Replacement

Intervention Type DEVICE

Replacement of the tricuspid valve through a transcatheter approach

Interventions

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Transcatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Intervention Type DEVICE

Other Intervention Names

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Edwards EVOQUE Tricuspid Valve Replacement System

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No