ProjectConduct IIT part2 – A prospective identification of procedure related variables associated with permanent…
Basic data
Acronym:
Conduct IIT part2
Title:
A prospective identification of procedure related variables associated with permanent pacemaker implantation in patients receiving an Edwards SAPIEN 3 valve via a transfemoral procedure
Duration:
17/01/2019 to 30/06/2022
Abstract / short description:
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.
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.
Involved staff
Managers
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Faculty of Medicine
University of Tübingen
University of Tübingen
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Internal Medicine Department III
Department of Internal Medicine
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Cloppenburg, Niedersachsen, Germany