Brief description of study

The PORTICO clinical study is a prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico Transcatheter Heart Valve and Delivery Systems (Portico) via transfemoral and alternative delivery methods. The purpose of this study is to evaluate the safety and effectiveness of the new St Jude Medical Portico Transcatheter Heart Valve and delivery systems. The study valve is made to replace your diseased aortic heart valve. The Portico Transcatheter Heart Valve is an investigational device. This means that the valve is being studied, and is not for sale in the United States. This study is collecting data on the valve and delivery system for review and approval by the Food and Drug Administration (FDA). This trial includes both high-risk and extreme-risk patients. Prior to randomization, patients will be classified as high or extreme risk and stratified by vascular access within each risk group. At the time of the primary analysis, the risk cohorts will be combined.

Clinical Study Identifier: s18-00941
ClinicalTrials.gov Identifier: NCT02000115
Principal Investigator: Richard K Schwartz.

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