This study is a retrospective, single center data collection to assess bleeding and vascular complications associated with TAVI when a SoloPath® Balloon Expandable TransFemoral Introducer is used for vascular access.
This study is intended to collect data on the rate of vascular complications in subjects having transfemoral TAVI when the SoloPath® Balloon Expandable TransFemoral Introducer is used as a guide for introduction and delivery of TAVI devices. The use of a small profile sheath could possibly reduce the incidence of post procedure vascular complications associated with TAVI and further enhance the safety of accessing the femoral delivery route. In addition, this study will examine the impact of arterial morphology and other subject risk factors as a predictor of clinical outcomes within 30 days following TAVI.
Study Type
OBSERVATIONAL
Enrollment
90
Montreal Heart Institute
Montreal, Ontario, Canada
Vascular Access Site Complications
Rate of VARC-2 defined vascular complications within 30 days of TAVI.
Time frame: withn 30 days of TAVI procedure
Bleeding Complications at the Access Site
VARC-2 defined vascular access site bleeding complications i.e. minor, major or life threatening bleeding
Time frame: within 30 days of TAVI procedure
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