Last updated on August 2019

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Brief description of study

The PORTICO IDE clinical trial 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.

Detailed Study Description

The PORTICO IDE trial will include approximately 758 randomized subjects at up to 70 investigational sites. The study is powered to analyze the high risk cohort and extreme risk cohort together against a commercially available control for the primary safety and effectiveness endpoints. In addition, data for each cohort will be analyzed separately in a subgroup analysis.

A minimum of two (2) and up to three (3) roll-in patients per primary implanting physician will be allowed. These roll-in subjects will be added to a Roll-in Registry. In addition, up to 100 subjects may be enrolled in a Valve-in-Valve registry. Implanting physicians with prior Portico experience and with a minimum of 3 implants in the last 6 months will not be required to include roll-in patients.

Registry data will not be included in the randomized cohort analysis, but will be analyzed and presented separately.

The FlexNav study will be conducted as a separate arm of the PORTICO IDE trial and will include 100 high or extreme risk patients. Safety data for the FlexNav Delivery System will be summarized and descriptively compared to the first-generation Portico Delivery System.

Following completion of enrollment in the randomized cohort, subjects will be eligible for enrollment in the Portico IDE Continued Access Protocol (CAP) Study.

The sponsor will submit a final clinical report for combined risk cohorts as enrollment and follow-up is completed according to the protocol.

Clinical Study Identifier: NCT02000115

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