The DefiPace Study

Recruiting

• Conditions: Post-operative Atrial Fibrillation POAF
• Interventions: Other: No intervention

• Registration Number: NCT04804748
• Lead Sponsor: Institut für Pharmakologie und Präventive Medizin

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

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 (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

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2023-03-28
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2026-01-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase A	No intervention	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	No intervention	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

Primary Outcome Measures

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

Trial Locations

Locations (10)

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Bavaria, Germany

Heart Center Dresden GmbH University Hospital; 🇩🇪 Dresden, Saxony, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Bavaria, Germany

University Hospital of Würzburg; 🇩🇪 Würzburg, Bavaria, Germany

Oldenburg Hospital AöR / Medical Campus University of Oldenburg; 🇩🇪 Oldenburg, Lower Saxony, Germany

Albert-Ludwigs-Universitaet Freiburg; 🇩🇪 Freiburg, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

University Hospital Jena; 🇩🇪 Jena, Germany

University Hospital Ulm; 🇩🇪 Ulm, Germany

Medical University of Vienna; 🇦🇹 Vienna, Austria