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Edwards Cardioband™ Tricuspid Valve Reconstruction System Early Feasibility Study

Overview

About this study

The purpose of this early feasibility study is to assess the safety and performance of the Edwards Cardioband™ FIT Valve Repair 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:

- Chronic functional tricuspid regurgitation (moderate or greater)

- Symptomatic despite medical therapy

- The local site Heart Team determines that the patient is appropriate for transcatheter
tricuspid reconstruction

Exclusion Criteria:

- Unsuitable anatomy

- Primary tricuspid valve disease

- Previous tricuspid valve repair or replacement

- Co-morbid condition(s) that, in the opinion of the investigator, could limit the
patient's ability to participate in the study, including compliance with follow-up
requirements, or that could impact the scientific integrity of the study

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

Eligibility last updated 9/22/22. 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-20440978

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