Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04804748
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-03-16
Brief Title:
The DefiPace Study
Sponsor:
Institut für Pharmakologie und Präventive Medizin
Organization:
Institut für Pharmakologie und Präventive Medizin
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Defipace
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
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 n50 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 n100 These patients will be followed-up with a phone call 30 days after 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 n50 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 n100 These patients will be followed-up with a phone call 30 days after surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None