Clinical trial NCT04804748: The DefiPace 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-operative Atrial Fibrillation POAF
Lead sponsor: Institut für Pharmakologie und Präventive Medizin
Sponsor class: NETWORK
Collaborators: name: Osypka AG
First posted: 2021-03-18
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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 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

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

Eligibility criteria: 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 outcomes:
measure: Incidence of POAF
timeFrame: 30 days
measure: Termination of POAF
timeFrame: 30 days
measure: Time in POAF
timeFrame: 30 days
measure: Time to cardioversion
timeFrame: 30 days
measure: Number of shocks
timeFrame: 30 days
measure: Energy requirements
timeFrame: 30 days
measure: POAF recurrence
timeFrame: 30 days
measure: Time in ICU
timeFrame: 30 days
measure: Procedural success
timeFrame: 30 days
measure: Time needed for electrode placement
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
state: Bavaria
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
state: Bavaria
city: Würzburg
country: Germany
facility: University Hospital of Würzburg
state: Bavaria
city: Oldenburg
country: Germany
facility: Oldenburg Hospital AöR / Medical Campus University of Oldenburg
state: Lower Saxony
city: Dresden
country: Germany
facility: Heart Center Dresden GmbH University Hospital
state: Saxony
city: Freiburg
country: Germany
facility: Albert-Ludwigs-Universitaet Freiburg
city: Hannover
country: Germany
facility: Hannover Medical School
city: Jena
country: Germany
facility: University Hospital Jena
city: Ulm
country: Germany
facility: University Hospital Ulm
Study officials:
affiliation: IPPMed
name: Peter Bramlage, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.