Post-operative Atrial Fibrillation POAFDefipaceNCT04804748
The DefiPace Study
An observational study of Post-operative Atrial Fibrillation POAF, run by Institut für Pharmakologie und Präventive Medizin at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Atrial Fibrillation POAF
- How many people
- 450 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 28 Mar 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
Germany9 sites, 9 recruiting
- Recruiting
Heart Center Dresden GmbH University Hospital
Dresden, Saxony, 01307
Tomas Madej, Dr. med.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Friedrich Mellert, PD Dr.med.
- Recruiting
Albert-Ludwigs-Universitaet Freiburg
Freiburg im Breisgau, 79106
Fatos Ballazhi, Dr. med.
- Recruiting
Hannover Medical School
Hanover, 30625
Heidi Niehaus, PD Dr. med.
- Recruiting
University Hospital Jena
Jena, 07747
Hristo Kirov, Dr. med.
- Recruiting
Klinikum Nürnberg
Nuremberg, Bavaria, 90419
Theodor Fischlein, Prof.Dr.med.
- Recruiting
Oldenburg Hospital AöR / Medical Campus University of Oldenburg
Oldenburg, Lower Saxony, 26133
Fritz Mellert, PD Dr. med.
- Recruiting
University Hospital Ulm
Ulm, 89081
Andreas Liebold, Prof.Dr.med.
- Recruiting
University Hospital of Würzburg
Würzburg, Bavaria, 97080
Mohamed Hassan
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Emilio Osorio, Dr. med.
About this study
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
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
- to document the standard of care in 50 patients with atrial fibrillation (AF)
- 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
Read the 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
- Conditions
- Post-operative Atrial Fibrillation POAF
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of POAF
Incidence of POAF
Measured: 30 days
Termination of POAF
Termination of POAF
Measured: 30 days
Time in POAF
Time in POAF (AF Burden)
Measured: 30 days
Time to cardioversion
Median time to cardioversion
Measured: 30 days
Number of shocks
Mean number of shocks per patient
Measured: 30 days
Energy requirements
Mean energy requirements (first/subsequent)
Measured: 30 days
POAF recurrence
POAF recurrence/repeat cardioversions
Measured: 30 days
Time in ICU
Time in ICU in hours
Measured: 30 days
Procedural success
Procedural success
Measured: 30 days
Time needed for electrode placement
Time needed for electrode placement
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start28 Mar 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-operative Atrial Fibrillation POAFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Pharmakologie und Präventive Medizin
- Sponsor type
- Research network
- Collaborators
- Osypka AG
- Responsible party
- Sponsor
- Investigators
- Peter Bramlage, Professor, Study director, IPPMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804748
- Sponsor's protocol ID
- IPPMed Defipace 202103
- Acronym
- Defipace
- Status last verified
- Jul 2026
- First submitted
- 16 Mar 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 12683560Liebold 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.
PubMed 9738643
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04804748
- Acronym / sponsor ID
- Defipace / IPPMed Defipace 202103
- Conditions
- Post-operative Atrial Fibrillation POAF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Institut für Pharmakologie und Präventive MedizinResearch network
- Collaborators
- Osypka AG
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- to document the standard of care in 50 patients with atrial fibrillation (AF)
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase A | – | Other: No interventionApproximately 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 | – | Other: No interventionApproximately 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Phase A Approximately 150 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) Phase B Approximately 300 consecutive patients undergoing elective cardiac surgery (bypass and / or valve surgery) with planned TMA implantation.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionno intervention | Other | Phase A, Phase B |
Primary outcome
Incidence of POAF
Time frame: 30 days
Incidence of POAF
Termination of POAF
Time frame: 30 days
Termination of POAF
Time in POAF
Time frame: 30 days
Time in POAF (AF Burden)
Time to cardioversion
Time frame: 30 days
Median time to cardioversion
Number of shocks
Time frame: 30 days
Mean number of shocks per patient
Energy requirements
Time frame: 30 days
Mean energy requirements (first/subsequent)
POAF recurrence
Time frame: 30 days
POAF recurrence/repeat cardioversions
Time in ICU
Time frame: 30 days
Time in ICU in hours
Procedural success
Time frame: 30 days
Procedural success
Time needed for electrode placement
Time frame: 30 days
Time needed for electrode placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 12683560Bechtel 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.
- Background: PubMed 9738643Liebold 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Bramlage, Professor study director
IPPMed
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Atrial Fibrillation POAF, run by Institut für Pharmakologie und Präventive Medizin at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Nitz, PhD (+49 447185033 ext. 27, susanne.nitz@ippmed.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of POAF (time frame: 30 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04804748, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.