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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02241382




Registration number
NCT02241382
Ethics application status
Date submitted
5/09/2014
Date registered
16/09/2014
Date last updated
26/01/2018

Titles & IDs
Public title
Cologne Cardioversion Study
Scientific title
Randomized Controlled Trial Comparing Internal vs External Cardioversion in ICD Patients
Secondary ID [1] 0 0
UKK-CCS-2014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Arrhythmia 0 0
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Internal Electrocardioversion
Treatment: Devices - External Electrocardioversion

Active comparator: External Electrocardioversion - Cardioversion with an external cardioverter-defibrillator with a step-up energy protocol (100, 150, 200, 360 J biphasic) in antero-posterior orientation, maintaining a \> 8 cm distance between shock electrodes and device and complying with a "cool-down" phase of 2 minute between shocks, if more than one shock is required.

Experimental: Internal Electrocardioversion - Cardioversion via the implanted ICD with a maximum energy synchronized shock (41 J, with a RV -\> SVC+can shock orientation in pts with SVC leads). After 1 ineffective internal shock, the patient will be counted as internal CV failure and cardioverted externally, following the same protocol as the external CV group.


Treatment: Devices: Internal Electrocardioversion
Cardioversion by internal shock application via the implanted ICD

Treatment: Devices: External Electrocardioversion
Cardioversion by external shock application via a cardioverter/defibrillator.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Combined Safety Endpoint
Assessment method [1] 0 0
Any one of the following as assessed by device interrogation: * a rise in threshold (at constant duration) of \>0.5V * exit block of one of the pacing leads * loss of programming of the device * a rise in shock impedance by 50% as compared to prior to CV * a drop in battery voltage of =0.2V within 2 weeks
Timepoint [1] 0 0
2 weeks after CV
Primary outcome [2] 0 0
Efficacy Endpoint: restoration of sinus rhythm
Assessment method [2] 0 0
Assessed by ECG, within the first seconds after DC shock application (via external CV or internal shock) - Restoration of sinus rhythm In all patients a single p wave after cardioversion counts as a successful shock. Early recurrence of AF does not count as shock failure. In case of early recurrence of AF/AT, the successful shock may be performed once more, according to randomization. Adjunctive antiarrhythmic drug administration is left to the physician's discretion
Timepoint [2] 0 0
Within 1 minute after CV
Secondary outcome [1] 0 0
Induction of ventricular fibrillation
Assessment method [1] 0 0
Inadvertent induction of VF during CV, assessed by 3 or 5 lead ECG monitoring during the procedure.
Timepoint [1] 0 0
during CV procedure
Secondary outcome [2] 0 0
Lead parameter indicators of impairment
Assessment method [2] 0 0
Assessed by device interrogation within 15 minutes after CV and at follow-up after 2 weeks: * Lead impedance \> 1000 Ohm * Lead impedance doubled * Ventricular lead sensing \< 2mV * Ventricular lead sensing halved, compared to prior to CV * Atrial lead sensing \< 1mV * Atrial lead sensing halved, compared to prior to CV
Timepoint [2] 0 0
within 15 minutes after CV and 2 weeks after CV
Secondary outcome [3] 0 0
Troponin
Assessment method [3] 0 0
Comparison of Troponin T levels prior to and 3h after cardioversion
Timepoint [3] 0 0
3h after CV
Secondary outcome [4] 0 0
Recurrence at follow-up
Assessment method [4] 0 0
Rhythm at follow-up assessed by ECG and device interrogation. Atrial fibrillation and atrial flutter or atrial tachycardia will be counted as recurrence.
Timepoint [4] 0 0
at follow-up 2 weeks after CV

Eligibility
Key inclusion criteria
* Age = 18 years
* Informed, written consent
* Atrial arrhythmia with indication for CV
* Status post ICD implantation, including CRT-D
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Age < 18 years
* Patients under guardianship or with mental disorders / disabilities
* ICD implantation < 4 weeks prior to CV
* ICD lead implantation < 4 weeks prior to CV
* Battery in EOL, ERM or ERI, ERT
* Indications of compromised leads (Impedance <200 or >2000 Ohm, Pacing threshold >5V/0.4ms), RV Sensing <4mV or RA sensing <0,1mV)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/01/2018
Sample size
Target
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Schleswig-Holstein
Country [2] 0 0
Germany
State/province [2] 0 0
Aachen
Country [3] 0 0
Germany
State/province [3] 0 0
Bad Oeynhausen
Country [4] 0 0
Germany
State/province [4] 0 0
Bonn
Country [5] 0 0
Germany
State/province [5] 0 0
Coburg
Country [6] 0 0
Germany
State/province [6] 0 0
Cologne
Country [7] 0 0
Germany
State/province [7] 0 0
Göttingen
Country [8] 0 0
Germany
State/province [8] 0 0
Hamburg
Country [9] 0 0
Germany
State/province [9] 0 0
Leverkusen
Country [10] 0 0
Germany
State/province [10] 0 0
Oldenburg

Funding & Sponsors
Primary sponsor type
Other
Name
Universitätsklinikum Köln
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Daniel Steven, Prof. Dr.
Address 0 0
University Hospital Cologne
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT02241382