NCT04804748

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: Institut für Pharmakologie und Präventive Medizin · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

Conditions

• Post-operative Atrial Fibrillation POAF

Interventions

Type	Name	Description
OTHER	No intervention	no intervention

Timeline

• Start date: 2023-03-28
• Primary completion: 2026-05-31
• Completion: 2026-08-31
• First posted: 2021-03-18
• Last updated: 2026-03-30

Locations

10 sites across 2 countries: Austria, Germany