Prospective, non-interventional, multi-center, international registry in two phases in consecutive patients undergoing elective cardiac surgery. The DefiPace registry is designed in two phases 1. to document the standard of care in 50 patients with atrial fibrillation (AF) 2. to assess the treatment and outcomes of patients with post-operative atrial fibrilllation using low-energy cardioversion and subsequent bi-atrial pacing in clinical practice in 100 patients
Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) * Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge * No use of an external bi-atrial pacing device * No use of Defipace * In-hospital data will be collected for all patients * Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery. Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation * In-hospital data will be collected for all patients * Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery
Study Type
OBSERVATIONAL
Enrollment
450
no intervention
Medical University of Vienna
Vienna, Austria
RECRUITINGUniversitätsklinikum Erlangen
Erlangen, Bavaria, Germany
RECRUITINGIncidence of POAF
Incidence of POAF
Time frame: 30 days
Termination of POAF
Termination of POAF
Time frame: 30 days
Time in POAF
Time in POAF (AF Burden)
Time frame: 30 days
Time to cardioversion
Median time to cardioversion
Time frame: 30 days
Number of shocks
Mean number of shocks per patient
Time frame: 30 days
Energy requirements
Mean energy requirements (first/subsequent)
Time frame: 30 days
POAF recurrence
POAF recurrence/repeat cardioversions
Time frame: 30 days
Time in ICU
Time in ICU in hours
Time frame: 30 days
Procedural success
Procedural success
Time frame: 30 days
Time needed for electrode placement
Time needed for electrode placement
Time frame: 30 days
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Klinikum Nürnberg
Nuremberg, Bavaria, Germany
University Hospital of Würzburg
Würzburg, Bavaria, Germany
RECRUITINGOldenburg Hospital AöR / Medical Campus University of Oldenburg
Oldenburg, Lower Saxony, Germany
RECRUITINGHeart Center Dresden GmbH University Hospital
Dresden, Saxony, Germany
RECRUITINGAlbert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, Germany
RECRUITINGHannover Medical School
Hanover, Germany
RECRUITINGUniversity Hospital Jena
Jena, Germany
RECRUITINGUniversity Hospital Ulm
Ulm, Germany
RECRUITING