The DefiPace Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Post-operative Atrial Fibrillation POAF. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Detailed description
Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery)
* Data regarding standard of care post-operative pacing and treatment of POAF, if applicable, will be collected from time of surgery until discharge * No use of an external bi-atrial pacing device * No use of Defipace * In-hospital data will be collected for all patients * Patients that developed POAF (n=50) will be followed-up with a phone call 30 days after surgery.
Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation
* In-hospital data will be collected for all patients * Use of the DefiPace system for the treatment (low-energy cardioversion) and post-operative prevention (bi-atrial pacing) of POAF will be documented (n=100). These patients will be followed-up with a phone call 30 days after surgery
Interventions
- Other No intervention
no intervention
Primary outcome measures
- Incidence of POAF [Time frame: 30 days]
- Termination of POAF [Time frame: 30 days]
- Time in POAF [Time frame: 30 days]
- Time to cardioversion [Time frame: 30 days]
- Number of shocks [Time frame: 30 days]
- Energy requirements [Time frame: 30 days]
- POAF recurrence [Time frame: 30 days]
- Time in ICU [Time frame: 30 days]
- Procedural success [Time frame: 30 days]
- Time needed for electrode placement [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Germany · 9 centers
- Universitätsklinikum Erlangen — Erlangen
- Klinikum Nürnberg — Nuremberg
- University Hospital of Würzburg — Würzburg
- Oldenburg Hospital AöR / Medical Campus University of Oldenburg — Oldenburg
- Heart Center Dresden GmbH University Hospital — Dresden
- Albert-Ludwigs-Universitaet Freiburg — Freiburg im Breisgau
- Hannover Medical School — Hanover
- University Hospital Jena — Jena
- … and 1 more center
Austria · 1 center
- Medical University of Vienna — Vienna
Publications
- Bechtel JF, Christiansen JF, Sievers HH, Bartels C. Low-energy cardioversion versus medical treatment for the termination of atrial fibrillation after CABG. Ann Thorac Surg. 2003 Apr;75(4):1185-8. doi: 10.1016/s0003-4975(02)04715-x. PMID 12683560
- Liebold A, Wahba A, Birnbaum DE. Low-energy cardioversion with epicardial wire electrodes: new treatment of atrial fibrillation after open heart surgery. Circulation. 1998 Sep 1;98(9):883-6. doi: 10.1161/01.cir.98.9.883. PMID 9738643
Identifiers
NCT: NCT04804748 · IPPMed Defipace 202103