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
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:
• 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
Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Germany
Heart Center Dresden GmbH University Hospital
RECRUITING
Dresden
Universitätsklinikum Erlangen
RECRUITING
Erlangen
Albert-Ludwigs-Universitaet Freiburg
RECRUITING
Freiburg Im Breisgau
Hannover Medical School
RECRUITING
Hanover
University Hospital Jena
RECRUITING
Jena
Klinikum Nürnberg
RECRUITING
Nuremberg
Oldenburg Hospital AöR / Medical Campus University of Oldenburg
RECRUITING
Oldenburg
University Hospital Ulm
RECRUITING
Ulm
University Hospital of Würzburg
RECRUITING
Würzburg
Contact Information
Primary
Susanne Nitz, PhD
susanne.nitz@ippmed.de
+49 447185033
Time Frame
Start Date:2023-03-28
Estimated Completion Date:2027-12-31
Participants
Target number of participants:450
Treatments
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