Advance 2: IF - THEN - ELSE Statements Multiple Condition and Alternative Results (Pascal Expression) Modified on: Tue, 22 Jan, 2019 at 2:06 PM. Users can use any normal operators or formulas which can be inserted in (condition). ELSE Statements Multiple Condition and Alternative Results (Pascal Expression) Modified on: Tue, 22 Jan, 2019.
Inclusion Criteria:. Signed and dated IRB/ethics committee approved study consent form prior to study related procedures. Eighteen (18) years of age or older. New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy. Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation. Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
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The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.Exclusion Criteria:. Patient in whom a TEE is contraindicated or screening TEE is unsuccessful. Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation. Mitral valve area (MVA). Layout table for additonal informationResponsible Party:Edwards LifesciencesClinicalTrials.gov Identifier:Other Study ID Numbers:2016-05First Posted:May 31, 2017Last Update Posted:July 29, 2019Last Verified:July 2019Individual Participant Data (IPD) Sharing Statement:Plan to Share IPD:UndecidedLayout table for additional informationStudies a U.S. FDA-regulated Drug Product:NoStudies a U.S.
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FDA-regulated Device Product:YesDevice Product Not Approved or Cleared by U.S. FDA:YesPediatric Postmarket Surveillance of a Device Product:NoProduct Manufactured in and Exported from the U.S.:YesAdditional relevant MeSH terms.