The DefiPace Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Post-operative Atrial Fibrillation POAF

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

• Study Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Susanne Nitz, PhD; Phone Number: 27 +49 447185033; Email: susanne.nitz@ippmed.de

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Emilio Osorio, Dr. med.
• Germany
  • Freiburg, Germany, 79106
    • Recruiting
    • Albert-Ludwigs-Universitaet Freiburg
    • Contact: Fatos Ballazhi, Dr. med.
  • Hannover, Germany, 30625
    • Recruiting
    • Hannover Medical School
    • Contact: Heidi Niehaus, PD Dr. med.
  • Jena, Germany, 07747
    • Recruiting
    • University Hospital Jena
    • Contact: Hristo Kirov, Dr. med.
  • Ulm, Germany, 89081
    • Recruiting
    • University Hospital Ulm
    • Contact: Andreas Liebold, Prof.Dr.med.
  • Bavaria
    • Nürnberg, Bavaria, Germany, 90419
      • Recruiting
      • Klinikum Nürnberg
      • Contact: Theodor Fischlein, Prof.Dr.med.
    • Würzburg, Bavaria, Germany, 97080
      • Recruiting
      • University Hospital of Würzburg
      • Contact: Mohamed Hassan
  • Lower Saxony
    • Oldenburg, Lower Saxony, Germany, 26133
      • Recruiting
      • Oldenburg Hospital AöR / Medical Campus University of Oldenburg
      • Contact: Fritz Mellert, PD Dr. med.
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Not yet recruiting
      • Heart Center Dresden GmbH University Hospital
      • Contact: Tomas Madej, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• Patient is scheduled to undergo elective open chest cardiac surgery (bypass and / or valve surgery)
• 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:

• Permanent AF at hospital admission
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut für Pharmakologie und Präventive Medizin
• Collaborators: Osypka AG
• Investigators: Study Director: Peter Bramlage, Professor, IPPMed

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: IPPMed Defipace 202103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No