Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
450 participants
OBSERVATIONAL
2023-03-28
2026-08-31
Brief Summary
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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
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Detailed Description
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* 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No intervention
no intervention
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
No intervention
no intervention
Interventions
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No intervention
no intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Osypka AG
UNKNOWN
Institut für Pharmakologie und Präventive Medizin
NETWORK
Responsible Party
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Principal Investigators
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Peter Bramlage, Professor
Role: STUDY_DIRECTOR
IPPMed
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Emilio Osorio, Dr. med.
Role: primary
Friedrich Mellert, PD Dr.med.
Role: primary
Theodor Fischlein, Prof.Dr.med.
Role: primary
Mohamed Hassan
Role: primary
Fritz Mellert, PD Dr. med.
Role: primary
Tomas Madej, Dr. med.
Role: primary
Fatos Ballazhi, Dr. med.
Role: primary
Heidi Niehaus, PD Dr. med.
Role: primary
Hristo Kirov, Dr. med.
Role: primary
Andreas Liebold, Prof.Dr.med.
Role: primary
References
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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.
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.
Other Identifiers
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IPPMed Defipace 202103
Identifier Type: -
Identifier Source: org_study_id
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