Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cologne Cardioversion Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02241382
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Universitätsklinikum Köln

Brief Summary:

Implantation of internal defibrillators, capable of monitoring the heart and shocking life threatening arrhythmias back to normal rhythm, for patients with severe heart failure increases the probability of survival. Arrhythmias of the atria of the heart are common in these patients. Administering a direct current electrical shock under anesthesia (cardioversion) is the method of choice to reestablish normal sinus rhythm in this instance. Safety and efficacy of external electrical cardioversion (CV) in patients with ICDs was demonstrated in several studies. Safety of internal cardioversion (shocking the heart back into normal rhythm via the implanted defibrillator) was described in several smaller trials.

Performing external instead of internal cardioversion in patients with implanted ICDs is more feasible for most hospitals, as CV can be performed without a programming computer and an additional specialist present, e.g. on the intensive care ward, and device interrogation can be done after CV at the remote ICD/pacemaker clinic.

No scientific data on safety and efficacy endpoints comparing internal vs external CV is currently available. The aim of the study is to compare external vs internal electrical cardioversion for atrial arrhythmias and establish a safety and efficacy profile for external and internal cardioversion in large cohort of ICD patients.


Condition or disease Intervention/treatment Phase
Atrial Arrhythmia Heart Failure Device: Internal Electrocardioversion Device: External Electrocardioversion Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Internal vs External Cardioversion in ICD Patients
Actual Study Start Date : September 2014
Actual Primary Completion Date : January 24, 2018
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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.
Device: External Electrocardioversion
Cardioversion by external shock application via a cardioverter/defibrillator.

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.
Device: Internal Electrocardioversion
Cardioversion by internal shock application via the implanted ICD




Primary Outcome Measures :
  1. Combined Safety Endpoint [ Time Frame: 2 weeks after CV ]

    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

  2. Efficacy Endpoint: restoration of sinus rhythm [ Time Frame: Within 1 minute after CV ]

    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



Secondary Outcome Measures :
  1. Induction of ventricular fibrillation [ Time Frame: during CV procedure ]
    Inadvertent induction of VF during CV, assessed by 3 or 5 lead ECG monitoring during the procedure.

  2. Lead parameter indicators of impairment [ Time Frame: within 15 minutes after CV and 2 weeks after CV ]

    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

  3. Troponin [ Time Frame: 3h after CV ]
    Comparison of Troponin T levels prior to and 3h after cardioversion

  4. Recurrence at follow-up [ Time Frame: at follow-up 2 weeks after CV ]
    Rhythm at follow-up assessed by ECG and device interrogation. Atrial fibrillation and atrial flutter or atrial tachycardia will be counted as recurrence.


Other Outcome Measures:
  1. Subgroup Analysis [ Time Frame: immediately after CV and at follow-up ]

    The following subgroups will be analyzed:

    • patients with CRT devices
    • patients with quadripolar leads
    • patients with ineffective external shock and crossover to external shock
    • patients with AV-VV delay optimization algorithms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Informed, written consent
  • Atrial arrhythmia with indication for CV
  • Status post ICD implantation, including CRT-D

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)

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): NCT02241382


Locations
Layout table for location information
Australia
Royal Adelaide Hospital
Adelaide, Australia
Germany
University Hospital Lübeck
Lübeck, Schleswig-Holstein, Germany
University Hospital Aachen
Aachen, Germany
Heart & Diabetes Center NRW
Bad Oeynhausen, Germany, 32545
University Hospital Bonn
Bonn, Germany
Klinikum Coburg GmbH
Coburg, Germany, 96450
University Hospital Cologne
Cologne, Germany, 50937
Vinzenz Hospital
Cologne, Germany
Krankenhaus Neu-Bethlehem
Göttingen, Germany, 37073
University Heart Center Hamburg
Hamburg, Germany, 20249
St.Georg Hospital
Hamburg, Germany
Klinikum Leverkusen GmbH
Leverkusen, Germany, 51375
Klinikum Oldenburg
Oldenburg, Germany, 26133
Sponsors and Collaborators
Universitätsklinikum Köln
Medtronic
Investigators
Layout table for investigator information
Study Director: Daniel Steven, Prof. Dr. University Hospital Cologne
Principal Investigator: Jakob Lüker, Dr. University Hospital Cologne
Layout table for additonal information
Responsible Party: Universitätsklinikum Köln
ClinicalTrials.gov Identifier: NCT02241382    
Other Study ID Numbers: UKK-CCS-2014
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases