Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial
Prospective, multi-center, randomized, controlled clinical study, designed to evaluate the safety and effectiveness of the SJM Portico THV & delivery systems.
The PORTICO 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, up to 100 subjects may be enrolled in a Valve-in-Valve registry.
SIMR (Sacramento/Valley Area) Please contact Beverly Seiler at SeilerB@sutterhealth.org about Study Portico IDEView study details on ClinicalTrials.gov
SMCS recruiting to valve-in-valve registry only.
May 16, 2016