Post-operative Atrial Fibrillation POAF
Conditions
Brief summary
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
Detailed description
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
Interventions
OTHERNo intervention
no intervention
Sponsors
Institut für Pharmakologie und Präventive Medizin
Osypka AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery) * Patient is at least 18 years old * Patient with isolated bypass surgery is at least 70 years old * Patient with valve surgery is at least 60 years old * Patient provides written informed consent prior to the procedure * Phase B only: patient is scheduled for TMA implantation during the elective cardiac surgery and is potentially eligible for DefiPace use
Exclusion criteria
* Clinical history of either permanent, persistend or paroxysmal atrial fibrillation * Permanent pacemaker/defibrillator, other intra-cardiac active implanted electronic devices * Minimally-invasive surgery * Recent stroke within the last 3 months * A history of or current endocarditis * Pregnacy at the time of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of POAF | 30 days | Incidence of POAF |
| Termination of POAF | 30 days | Termination of POAF |
| Time in POAF | 30 days | Time in POAF (AF Burden) |
| Time to cardioversion | 30 days | Median time to cardioversion |
| Number of shocks | 30 days | Mean number of shocks per patient |
| Energy requirements | 30 days | Mean energy requirements (first/subsequent) |
| POAF recurrence | 30 days | POAF recurrence/repeat cardioversions |
| Time in ICU | 30 days | Time in ICU in hours |
| Procedural success | 30 days | Procedural success |
| Time needed for electrode placement | 30 days | Time needed for electrode placement |
Countries
Austria, Germany
Contacts
CONTACTSusanne Nitz, PhD
STUDY_DIRECTORPeter Bramlage, Professor
IPPMed
Outcome results
None listed