No intervention
Otherno intervention
Recruiting
NCT Number: NCT04804748
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
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Medical University of Vienna, Vienna, Austria
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About this study
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
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Incidence of POAF
Time frame: 30 days
Incidence of POAF
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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
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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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Institut für Pharmakologie und Präventive Medizin
Network
Collaborators
- Osypka AG
Registry information
Official study 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
Acronym: Defipace
Important dates
- Study start
- 2023
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Mar 18, 2021
- Registry last updated
- Jul 30, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.