Overview
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
- to document the standard of care in 50 patients with atrial fibrillation (AF)
- 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
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