The DefiPace Study

NCT04804748 | Recruiting

• 1 other identifier: IPPMed Defipace 202103
• Study Type: observational
• Target: 450
• Locations: 2 countries
• Sites: 10

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. 1.to document the standard of care in 50 patients with atrial fibrillation (AF)
2. 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

Conditions

Post-operative Atrial Fibrillation POAF

Outcome Measures

Primary Outcomes (10)

• Incidence of POAF

  Incidence of POAF

  30 days

• Termination of POAF

  Termination of POAF

  30 days

• Time in POAF

  Time in POAF (AF Burden)

  30 days

• Time to cardioversion

  Median time to cardioversion

  30 days

• Number of shocks

  Mean number of shocks per patient

  30 days

• Energy requirements

  Mean energy requirements (first/subsequent)

  30 days

• POAF recurrence

  POAF recurrence/repeat cardioversions

  30 days

• Time in ICU

  Time in ICU in hours

  30 days

• Procedural success

  Procedural success

  30 days

• Time needed for electrode placement

  Time needed for electrode placement

  30 days

Study Arms (2)

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

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

Other: No intervention

Interventions

No intervention OTHER

no intervention

Phase A; Phase B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut für Pharmakologie und Präventive Medizin: lead
• Osypka AG: collaborator

Study Sites (10)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Universitätsklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, Bavaria, 90419, Germany

RECRUITING

University Hospital of Würzburg

Würzburg, Bavaria, 97080, Germany

RECRUITING

Oldenburg Hospital AöR / Medical Campus University of Oldenburg

Oldenburg, Lower Saxony, 26133, Germany

RECRUITING

Heart Center Dresden GmbH University Hospital

Dresden, Saxony, 01307, Germany

RECRUITING

Albert-Ludwigs-Universitaet Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Hannover Medical School

Hanover, 30625, Germany

RECRUITING

University Hospital Jena

Jena, 07747, Germany

RECRUITING

University Hospital Ulm

Ulm, 89081, Germany

RECRUITING

Related Publications (2)

• 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.

  PMID: 12683560 BACKGROUND

• 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.

  PMID: 9738643 BACKGROUND

Study Officials

• Peter Bramlage, Professor

  IPPMed

  STUDY DIRECTOR

Central Study Contacts

Susanne Nitz, PhD

CONTACT

+49 447185033; susanne.nitz@ippmed.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: March 28, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9); AU (1)