The DefiPace Study (Defipace)

July 29, 2026 updated by: Institut für Pharmakologie und Präventive Medizin

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
        • Contact:
          • Emilio Osorio, Dr. med.
  • Germany
      • Freiburg im Breisgau, Germany, 79106
        • Recruiting
        • Albert-Ludwigs-Universitaet Freiburg
        • Contact:
          • Fatos Ballazhi, Dr. med.
      • Hanover, 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
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
        • Contact:
          • Friedrich Mellert, PD Dr.med.
      • Nuremberg, 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
        • Recruiting
        • Heart Center Dresden GmbH University Hospital
        • Contact:
          • Tomas Madej, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of POAF
Time Frame: 30 days
Incidence of POAF
30 days
Termination of POAF
Time Frame: 30 days
Termination of POAF
30 days
Time in POAF
Time Frame: 30 days
Time in POAF (AF Burden)
30 days
Time to cardioversion
Time Frame: 30 days
Median time to cardioversion
30 days
Number of shocks
Time Frame: 30 days
Mean number of shocks per patient
30 days
Energy requirements
Time Frame: 30 days
Mean energy requirements (first/subsequent)
30 days
POAF recurrence
Time Frame: 30 days
POAF recurrence/repeat cardioversions
30 days
Time in ICU
Time Frame: 30 days
Time in ICU in hours
30 days
Procedural success
Time Frame: 30 days
Procedural success
30 days
Time needed for electrode placement
Time Frame: 30 days
Time needed for electrode placement
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut für Pharmakologie und Präventive Medizin

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Osypka AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Peter Bramlage, Professor, IPPMed

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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