Optimize PRO Study (NCT04091048) | Clinical Trial Compass
CompletedNot Applicable
Optimize PRO Study
United States1,127 participantsStarted 2019-09-16
Plain-language summary
The purpose of this study is to collect clinical evidence on valve performance and procedural outcomes associated with an "optimized" TAVR care pathway and post-TAVR conduction disturbance pathway while using the Evolut™ PRO and Evolut™ PRO+ devices.
The purpose of the addendum is to collect post-market clinical evidence on valve performance and procedural outcomes associated with the Evolut FX Device.
Who can participate
SexALL
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Inclusion Criteria:
* Acceptable candidate for treatment with the Evolut™ PRO or Evolut™ PRO+ system (FX system for the addendum where applicable) in accordance with the Instructions for Use and local regulations;
* Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
* Subject and the treating physician agree that the subject will return for all required post procedure follow-up visits;
* Anatomically suitable for transfemoral TAVR with the Medtronic TAVR system;
* Subject meets the legal minimum age to provide Informed Consent based on local regulatory requirements.
Exclusion Criteria:
* Contraindicated for treatment with the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable) in accordance with the Instructions for Use
* Anatomically not suitable for the Evolut™ PRO or Evolut™ PRO+ or FX system (where applicable);
* Previous aortic valve replacement
* Reduced ventricular function with left ventricular ejection fraction (LVEF) \<35% as measured by resting echocardiogram;
* Frailty assessments identify:
* Subject is \<80 years of age and three or more of the following apply; OR subject is \> 80 years of age and two or more of the following apply
* Wheelchair bound
* Resides in an institutional care facility (e.g. nursing home, skilled care center)
* Body Mass Index \<20kg/m2
* Grip strength \<16kg
* Katz Index score ≤4
* Albumin \<3.5 g/dL
* Bicus…