The DefiPace Study

Post-operative Atrial Fibrillation POAF Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804748
• Other study ID #: IPPMed Defipace 202103
• Status: Recruiting
• Start date: March 28, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: Institut für Pharmakologie und Präventive Medizin
• Contact: Susanne Nitz, PhD
• Phone: +49 447185033
• Email: susanne.nitz[@]ippmed.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery)

• 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:

• Permanent AF at hospital admission

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-operative Atrial Fibrillation POAF

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Germany	Heart Center Dresden GmbH University Hospital	Dresden	Saxony
Germany	Albert-Ludwigs-Universitaet Freiburg	Freiburg
Germany	Hannover Medical School	Hannover
Germany	University Hospital Jena	Jena
Germany	Klinikum Nürnberg	Nürnberg	Bavaria
Germany	Oldenburg Hospital AöR / Medical Campus University of Oldenburg	Oldenburg	Lower Saxony
Germany	University Hospital Ulm	Ulm
Germany	University Hospital of Würzburg	Würzburg	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Pharmakologie und Präventive Medizin	Osypka AG

Countries where clinical trial is conducted

Austria,  Germany, 

References & Publications (2)

Bechtel JF, Christiansen JF, Sievers HH, Bartels C. Low-energy cardioversion versus medical treatment for the termination of atrial fibrillation after CABG. Ann Thorac Surg. 2003 Apr;75(4):1185-8. doi: 10.1016/s0003-4975(02)04715-x. — View Citation

Liebold A, Wahba A, Birnbaum DE. Low-energy cardioversion with epicardial wire electrodes: new treatment of atrial fibrillation after open heart surgery. Circulation. 1998 Sep 1;98(9):883-6. doi: 10.1161/01.cir.98.9.883. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POAF	Incidence of POAF	30 days
Primary	Termination of POAF	Termination of POAF	30 days
Primary	Time in POAF	Time in POAF (AF Burden)	30 days
Primary	Time to cardioversion	Median time to cardioversion	30 days
Primary	Number of shocks	Mean number of shocks per patient	30 days
Primary	Energy requirements	Mean energy requirements (first/subsequent)	30 days
Primary	POAF recurrence	POAF recurrence/repeat cardioversions	30 days
Primary	Time in ICU	Time in ICU in hours	30 days
Primary	Procedural success	Procedural success	30 days
Primary	Time needed for electrode placement	Time needed for electrode placement	30 days