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A Study to Evaluate the Safety and Effectiveness of the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement

Overview

About this study

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Symptomatic tricuspid regurgitation (TR) despite medical therapy

- TR graded as severe or greater

- Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria:

- Tricuspid valve anatomic contraindications

- Need for emergent or urgent surgery or any planned cardiac surgery within the next 12
months

- Hemodynamic instability

- Refractory heart failure requiring advanced intervention

- Currently participating in another investigational study in which the patient has not
reached a primary endpoint

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/30/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mackram Eleid, M.D.

Open for enrollment

Contact information:

Structural Heart Disease Research Coordinators

(507) 255-6133

More information

Publications

Publications are currently not available

More about research at Mayo Clinic

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CLS-20508000

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