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The DefiPace Study

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ClinicalTrials.gov Identifier: NCT04804748
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : October 6, 2022
Sponsor:
Collaborator:
Osypka AG
Information provided by (Responsible Party):
Institut für Pharmakologie und Präventive Medizin

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

Condition or disease
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

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : November 15, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Incidence of POAF [ Time Frame: 30 days ]
    Incidence of POAF

  2. Termination of POAF [ Time Frame: 30 days ]
    Termination of POAF

  3. Time in POAF [ Time Frame: 30 days ]
    Time in POAF (AF Burden)

  4. Time to cardioversion [ Time Frame: 30 days ]
    Median time to cardioversion

  5. Number of shocks [ Time Frame: 30 days ]
    Mean number of shocks per patient

  6. Energy requirements [ Time Frame: 30 days ]
    Mean energy requirements (first/subsequent)

  7. POAF recurrence [ Time Frame: 30 days ]
    POAF recurrence/repeat cardioversions

  8. Time in ICU [ Time Frame: 30 days ]
    Time in ICU in hours

  9. Procedural success [ Time Frame: 30 days ]
    Procedural success

  10. Time needed for electrode placement [ Time Frame: 30 days ]
    Time needed for electrode placement



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04804748


Contacts
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Contact: Beate Botta, PhD +49 447185033 ext 25 beate.botta@ippmed.de

Sponsors and Collaborators
Institut für Pharmakologie und Präventive Medizin
Osypka AG
Investigators
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Study Director: Peter Bramlage, Professor IPPMed
Publications:
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Responsible Party: Institut für Pharmakologie und Präventive Medizin
ClinicalTrials.gov Identifier: NCT04804748    
Other Study ID Numbers: IPPMed Defipace 202103
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: October 6, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes