Actively Recruiting
The DefiPace Study
Led by Institut für Pharmakologie und Präventive Medizin · Updated on 2026-03-30
450
Participants Needed
10
Research Sites
178 weeks
Total Duration
On this page
Sponsors
I
Institut für Pharmakologie und Präventive Medizin
Lead Sponsor
O
Osypka AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
The DefiPace Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Clinical history of either permanent, persistent 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
- Pregnancy at the time of surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
2
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
3
Klinikum Nürnberg
Nuremberg, Bavaria, Germany, 90419
Actively Recruiting
4
University Hospital of Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
5
Oldenburg Hospital AöR / Medical Campus University of Oldenburg
Oldenburg, Lower Saxony, Germany, 26133
Actively Recruiting
6
Heart Center Dresden GmbH University Hospital
Dresden, Saxony, Germany, 01307
Actively Recruiting
7
Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
8
Hannover Medical School
Hanover, Germany, 30625
Actively Recruiting
9
University Hospital Jena
Jena, Germany, 07747
Actively Recruiting
10
University Hospital Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
S
Susanne Nitz, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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