The DefiPace Study

Recruiting now

Conditions studied: Post-operative Atrial Fibrillation POAF

In brief

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

Key facts

Study ID

NCT04804748

Run by

Institut für Pharmakologie und Präventive Medizin

People needed

450

Starts

2023-03-28

Expected to finish

2027-12-31

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• Medical University of Vienna — Vienna, Austria (enrolling)
• Universitätsklinikum Erlangen — Erlangen, Bavaria, Germany (enrolling)
• Klinikum Nürnberg — Nuremberg, Bavaria, Germany (enrolling)
• University Hospital of Würzburg — Würzburg, Bavaria, Germany (enrolling)
• Oldenburg Hospital AöR / Medical Campus University of Oldenburg — Oldenburg, Lower Saxony, Germany (enrolling)
• Heart Center Dresden GmbH University Hospital — Dresden, Saxony, Germany (enrolling)
• Albert-Ludwigs-Universitaet Freiburg — Freiburg im Breisgau, Germany (enrolling)
• Hannover Medical School — Hanover, Germany (enrolling)
• University Hospital Jena — Jena, Germany (enrolling)
• University Hospital Ulm — Ulm, Germany (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.