The DefiPace Study
Recruiting · NCT04804748 · Observational (researchers observe without assigning treatment) · Lead sponsor: Institut für Pharmakologie und Präventive Medizin
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
10 locations listed.
- Albert-Ludwigs-Universitaet Freiburg - Freiburg im Breisgau, Germany
- Hannover Medical School - Hanover, Germany
- University Hospital Jena - Jena, Germany
- University Hospital Ulm - Ulm, Germany
- Medical University of Vienna - Vienna, Austria
- Universitätsklinikum Erlangen - Erlangen, Bavaria, Germany
- Klinikum Nürnberg - Nuremberg, Bavaria, Germany
- University Hospital of Würzburg - Würzburg, Bavaria, Germany
- Oldenburg Hospital AöR / Medical Campus University of Oldenburg - Oldenburg, Lower Saxony, Germany
- Heart Center Dresden GmbH University Hospital - Dresden, Saxony, Germany