Registry for patients with post-operative atrial fibrillation after cardiac surgery
Official title: 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
Run by Institut für Pharmakologie und Präventive Medizin · NCT04804748 · Data updated 2026-11-12
This study is looking at how patients who develop irregular heartbeats after heart surgery are treated and what the standard care looks like.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Institut für Pharmakologie und Präventive Medizin Research network |
| Locations | 10 sites (Vienna and 9 other locations) |
| Status | Recruiting |
| Started | March 28, 2023 |
| Main results expected | September 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT04804748 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults scheduled for elective open chest cardiac surgery, particularly those undergoing bypass or valve surgery.
✕Probably not a fit
Patients with a history of permanent, persistent, or paroxysmal atrial fibrillation or those with implanted electronic devices will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The DefiPace registry is a prospective, non-interventional, multi-center international study that aims to document the standard of care for patients undergoing elective cardiac surgery and assess the treatment outcomes for those who develop post-operative atrial fibrillation (POAF). The study is divided into two phases: the first phase involves collecting data on 150 patients to establish standard care practices, while the second phase focuses on 300 patients, specifically evaluating the use of low-energy cardioversion and bi-atrial pacing in treating POAF. Data will be collected from the time of surgery until discharge, with follow-up phone calls conducted 30 days post-surgery for patients who develop POAF.
Why it matters
Potential benefit: If successful, this study could improve the management and outcomes of patients experiencing post-operative atrial fibrillation.
How similar studies have gone: Similar studies have shown promise in managing post-operative atrial fibrillation, but this specific approach is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
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Medical University of Vienna
Vienna, Austria Recruiting -
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany Recruiting -
Klinikum Nürnberg
Nuremberg, Bavaria, Germany Recruiting -
University Hospital of Würzburg
Würzburg, Bavaria, Germany Recruiting -
Oldenburg Hospital AöR / Medical Campus University of Oldenburg
Oldenburg, Lower Saxony, Germany Recruiting -
Heart Center Dresden GmbH University Hospital
Dresden, Saxony, Germany Recruiting
Show 4 more locations
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Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, Germany Recruiting -
Hannover Medical School
Hanover, Germany Recruiting -
University Hospital Jena
Jena, Germany Recruiting -
University Hospital Ulm
Ulm, Germany Recruiting
Study contacts
- Study coordinator: Susanne Nitz, PhD
- Email: susanne.nitz@ippmed.de
- Phone: +49 447185033
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Anthocyanin-rich grape powder to prevent post-operative atrial fibrillation
We will test whether taking freeze-dried, anthocyanin-rich table grape powder before and after elective mitral valve surgery can reduce the chance of developing atrial fibrillation in adults aged 50–79 who are in normal sinus rhythm.
-
Colchicine to lower inflammation and prevent atrial fibrillation after coronary bypass
This trial tests whether giving colchicine to adults having coronary artery bypass (CABG) can lower inflammation and reduce the chance of atrial fibrillation after surgery.
-
Preventing atrial fibrillation with surgical ablation and left atrial appendage clipping during heart surgery
This trial tests whether adding surgical ablation and clipping of the left atrial appendage during routine open-heart surgery can prevent postoperative and later atrial fibrillation in older patients at higher stroke risk.
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Investigating Atrial Fibrillation After Heart Surgery
This study looks at how common irregular heartbeats are after heart surgery and what factors might increase the risk for patients in Thailand.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.