The DefiPace Study

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Post-operative Atrial Fibrillation POAF

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase A<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

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