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Primary Diagnosis

Mitral Valve Disease

​​Study Purpose

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and function of the Edwards Lifesciences Cardi-AQ-Edwards™ Transcatheter Mitral Valve with the Transseptal Delivery System.

Principal Investigator: Robert L. Smith, II, MD

Trial Details

Locations: Baylor Scott & White The Heart Hospital – Plano

Sponsor: Edwards Lifesciences

IRB Number: 014-278

Trial Status: Enrolling

Exclusions: Adults only

Change in Care: Participating may change your care

Contact Information:

Brittany Zingler, RN

Necole Kell, RN

Full Protocol Title

Early Feasibility Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System For Treatment of Moderate to Severe Mitral Regurgitation

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