ClinicaliQ Trial Snapshot
- Portico Next Generation Approval Study — Active Not Recruiting • Non-phase study • NCT04011722.
- Portico Next Generation Approval Study.
- Study testing a new heart valve for high-risk patients, measuring safety at 30 days and leakage around the valve.
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What This Trial Is Studying
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval. Conditions: Symptomatic Severe Aortic Stenosis Interventions: Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System Lead…