Status:
RECRUITING
The DefiPace Study
Lead Sponsor:
Institut für Pharmakologie und Präventive Medizin
Collaborating Sponsors:
Osypka AG
Conditions:
Post-operative Atrial Fibrillation POAF
Eligibility:
All Genders
18+ years
Brief 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...
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04804748
Start Date
March 28 2023
End Date
August 31 2026
Last Update
October 1 2024
Active Locations (10)
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1
Medical University of Vienna
Vienna, Austria, 1090
2
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany, 91054
3
Klinikum Nürnberg
Nuremberg, Bavaria, Germany, 90419
4
University Hospital of Würzburg
Würzburg, Bavaria, Germany, 97080