RecruitingNCT04804748

The DefiPace Study

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

Sponsor

Institut für Pharmakologie und Präventive Medizin

Enrollment

450 participants

Start Date

Mar 28, 2023

Study Type

OBSERVATIONAL

Conditions

Post-operative Atrial Fibrillation (POAF)

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a combined pacemaker-defibrillator device implanted during open-heart surgery (bypass or valve surgery) can reduce the risk of dangerous heart rhythms and sudden death in older patients, who are at higher risk after cardiac surgery. **You may be eligible if...** - You are scheduled for open-heart surgery (bypass and/or valve surgery) - You are at least 18 years old overall - If having bypass surgery only: you are at least 70 years old - If having valve surgery: you are at least 60 years old - You have given written informed consent **You may NOT be eligible if...** - You already have a pacemaker or defibrillator - You have a condition that makes device implantation unsafe - You are unable to consent to the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERNo intervention

no intervention

Locations(10)

Medical University of Vienna

Vienna, Austria

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Klinikum Nürnberg

Nuremberg, Bavaria, Germany

University Hospital of Würzburg

Würzburg, Bavaria, Germany

Oldenburg Hospital AöR / Medical Campus University of Oldenburg

Oldenburg, Lower Saxony, Germany

Heart Center Dresden GmbH University Hospital

Dresden, Saxony, Germany

Albert-Ludwigs-Universitaet Freiburg

Freiburg im Breisgau, Germany

Hannover Medical School

Hanover, Germany

University Hospital Jena

Jena, Germany

University Hospital Ulm

Ulm, Germany

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