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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04804748




Registration number
NCT04804748
Ethics application status
Date submitted
16/03/2021
Date registered
18/03/2021

Titles & IDs
Public title
The DefiPace Study
Scientific 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
Secondary ID [1] 0 0
IPPMed Defipace 202103
Universal Trial Number (UTN)
Trial acronym
Defipace
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative Atrial Fibrillation POAF 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

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


Other interventions: No intervention
no intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of POAF
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Termination of POAF
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Time in POAF
Timepoint [3] 0 0
30 days
Primary outcome [4] 0 0
Time to cardioversion
Timepoint [4] 0 0
30 days
Primary outcome [5] 0 0
Number of shocks
Timepoint [5] 0 0
30 days
Primary outcome [6] 0 0
Energy requirements
Timepoint [6] 0 0
30 days
Primary outcome [7] 0 0
POAF recurrence
Timepoint [7] 0 0
30 days
Primary outcome [8] 0 0
Time in ICU
Timepoint [8] 0 0
30 days
Primary outcome [9] 0 0
Procedural success
Timepoint [9] 0 0
30 days
Primary outcome [10] 0 0
Time needed for electrode placement
Timepoint [10] 0 0
30 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2026
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Germany
State/province [2] 0 0
Bavaria
Country [3] 0 0
Germany
State/province [3] 0 0
Lower Saxony
Country [4] 0 0
Germany
State/province [4] 0 0
Saxony
Country [5] 0 0
Germany
State/province [5] 0 0
Freiburg
Country [6] 0 0
Germany
State/province [6] 0 0
Hannover
Country [7] 0 0
Germany
State/province [7] 0 0
Jena
Country [8] 0 0
Germany
State/province [8] 0 0
Ulm

Funding & Sponsors
Primary sponsor type
Other
Name
Institut für Pharmakologie und Präventive Medizin
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Osypka AG
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Bramlage, Professor
Address 0 0
IPPMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Susanne Nitz, PhD
Address 0 0
Country 0 0
Phone 0 0
+49 447185033
Fax 0 0
Email 0 0
susanne.nitz@ippmed.de
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04804748