The DefiPace Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut für Pharmakologie und Präventive Medizin
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- No intervention
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Institut für Pharmakologie und Präventive Medizin
Lead sponsor
Osypka AG
Collaborator
Source ClinicalTrials.gov