Conduct IIT part2

A prospective identification of procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve via a transfemoral procedure

17.01.2019 bis 30.06.2022

Hypothesis: There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI

Method: Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valves.
Additional assessment of calcification using a CT data core lab. Statistical analysis of the obtained dataset with respect to the objectives of the registry.

Objectives: Increase the power versus pre-existing database analyses from single centres in an effort to identify predictors of PPI (risk factors versus procedural) in patients with a high risk for PPI who will be preferable included. The aim will be to identify general procedural predictors of PPI post TAVI with the Edwards SAPIEN 3 valves which when identified and avoided will reduce the need of PPI in the future.