RecruitingNCT06569602

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

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device


Sponsor

Edwards Lifesciences

Enrollment

500 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Plain Language Summary

Simplified for easier understanding

This real-world study tracks the safety and clinical outcomes of patients who have received the EVOQUE transcatheter tricuspid valve replacement system across European medical centers. The tricuspid valve is on the right side of the heart; when it leaks severely, the EVOQUE device can replace it without open heart surgery. **You may be eligible if:** - Your heart team has already decided that you are a suitable candidate for transcatheter tricuspid valve replacement with the EVOQUE system, based on the current approved guidelines - You are willing to attend follow-up appointments - You are able to provide written informed consent **You may NOT be eligible if:** - You are currently enrolled in another interventional drug, biologic, or device clinical trial that has not yet finished - You are considered a vulnerable patient unable to make independent decisions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach


Locations(2)

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Inselspital

Bern, Switzerland

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NCT06569602


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