Registry for patients with post-operative atrial fibrillation after cardiac surgery

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

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
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut für Pharmakologie und Präventive Medizin (network)
• Locations: 10 sites (Vienna and 9 other locations)
• Trial ID: NCT04804748 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for elective open chest cardiac surgery, particularly those undergoing bypass or valve surgery.

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.

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 performed: Similar studies have shown promise in managing post-operative atrial fibrillation, but this specific approach is novel.

Eligibility 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 this trial is running

Vienna and 9 other locations

• 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)
• 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

Conditions: Post-operative Atrial Fibrillation POAF