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
Institut für Pharmakologie und Präventive Medizin
450 participants
Mar 28, 2023
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria6
- 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 Criteria6
- 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
Interventions
no intervention
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT04804748