RECRUITINGOBSERVATIONAL
The DefiPace Study
Safety and Efficacy of Low-energy Electrical Cardioversion With or Without Bi-atrial Pacing in Patients With Post-operative Atrial Fibrillation in a Real World Setting - The DefiPace Study
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
No intervention
no intervention
Locations (10)
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
Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, Germany
Hannover Medical School
Hanover, Germany
University Hospital Jena
Jena, Germany
University Hospital Ulm
Ulm, Germany