Cologne Cardioversion Study

NCT02241382 | Completed DMC

• 1 other identifier: UKK-CCS-2014
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 13

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.

Conditions

Atrial Arrhythmia; Heart Failure

Outcome Measures

Primary Outcomes (2)

• Combined Safety Endpoint

  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 weeks after CV

• Efficacy Endpoint: restoration of sinus rhythm

  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

  Within 1 minute after CV

Secondary Outcomes (4)

• Induction of ventricular fibrillation

  during CV procedure

• Lead parameter indicators of impairment

  within 15 minutes after CV and 2 weeks after CV

• Troponin

  3h after CV

• Recurrence at follow-up

  at follow-up 2 weeks after CV

Other Outcomes (1)

• Subgroup Analysis

  immediately after CV and at follow-up

Study Arms (2)

External Electrocardioversion

ACTIVE COMPARATOR

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

Internal Electrocardioversion

EXPERIMENTAL

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

Interventions

Internal Electrocardioversion DEVICE

Cardioversion by internal shock application via the implanted ICD

Internal Electrocardioversion

External Electrocardioversion DEVICE

Cardioversion by external shock application via a cardioverter/defibrillator.

External Electrocardioversion

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Köln: lead
• Medtronic: collaborator

Study Sites (13)

Royal Adelaide Hospital

Adelaide, Australia

Location

University Hospital Lübeck

Lübeck, Schleswig-Holstein, Germany

Location

University Hospital Aachen

Aachen, Germany

Location

Heart & Diabetes Center NRW

Bad Oeynhausen, 32545, Germany

Location

University Hospital Bonn

Bonn, Germany

Location

Klinikum Coburg GmbH

Coburg, 96450, Germany

Location

University Hospital Cologne

Cologne, 50937, Germany

Location

Vinzenz Hospital

Cologne, Germany

Location

Krankenhaus Neu-Bethlehem

Göttingen, 37073, Germany

Location

University Heart Center Hamburg

Hamburg, 20249, Germany

Location

St.Georg Hospital

Hamburg, Germany

Location

Klinikum Leverkusen GmbH

Leverkusen, 51375, Germany

Location

Klinikum Oldenburg

Oldenburg, 26133, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Daniel Steven, Prof. Dr.

  University Hospital Cologne

  STUDY DIRECTOR

• Jakob Lüker, Dr.

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 16, 2014
• Study Start: September 1, 2014
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: January 26, 2018

Record last verified: 2018-01

Locations

AU (1); DE (12)