Clinical Trials in Germany / NCT04804748
Recruiting
Observational
The DefiPace Study
NCT04804748 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Post-operative Atrial Fibrillation POAF
Investigational drug(s) / intervention(s)
No intervention
No intervention: no intervention
Study 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
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
Primary outcome measure(s)
- Incidence of POAF — 30 days
Incidence of POAF - Termination of POAF — 30 days
Termination of POAF - Time in POAF — 30 days
Time in POAF (AF Burden) - Time to cardioversion — 30 days
Median time to cardioversion - Number of shocks — 30 days
Mean number of shocks per patient - Energy requirements — 30 days
Mean energy requirements (first/subsequent) - POAF recurrence — 30 days
POAF recurrence/repeat cardioversions - Time in ICU — 30 days
Time in ICU in hours - Procedural success — 30 days
Procedural success - Time needed for electrode placement — 30 days
Time needed for electrode placement
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | Recruiting |
| Universitätsklinikum Erlangen | Erlangen | Bavaria | Recruiting |
| Klinikum Nürnberg | Nuremberg | Bavaria | Recruiting |
| University Hospital of Würzburg | Würzburg | Bavaria | Recruiting |
| Oldenburg Hospital AöR / Medical Campus University of Oldenburg | Oldenburg | Lower Saxony | Recruiting |
| Heart Center Dresden GmbH University Hospital | Dresden | Saxony | Recruiting |
| Albert-Ludwigs-Universitaet Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| Hannover Medical School | Hanover | Germany | Recruiting |
| University Hospital Jena | Jena | Germany | Recruiting |
| University Hospital Ulm | Ulm | Germany | Recruiting |
More Institut für Pharmakologie und Präventive Medizin trials in Germany
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Inspiris Resilia Durability Registry
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04804748 on ClinicalTrials.gov ↗ ← All trials in Germany