NCT02317029

Brief Summary

Background: Cardiac arrhythmias can be terminated by electrical current applied by an external defibrillator. This treatment, named cardioversion, has been used for decades in the treatment of atrial fibrillation. Several kinds of defibrillators exist, though the relative efficacy and safety of these defibrillators is not clear. During cardioversion, oxygen is being administered, and it has been a long-held belief that oxygen is always beneficial for the patient. This is now being challenged by recent studies suggesting excessive oxygenation to be potentially dangerous for the patients. Objective:

  1. 1.To compare the efficiency and safety of two different defibrillators
  2. 2.To investigate the effects of excessive oxygen on injury of the heart following cardioversion.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1.2 years

First QC Date

March 18, 2014

Last Update Submit

May 22, 2018

Conditions

Atrial FibrillationAtrial Flutter

Keywords

CardioversionCardiac ArrythmiasMyocardial InjuryDefibrillatorsBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Change in Hs-cTnI and Hs-cTnT for room air versus hyperoxia

    High sensitive cardiac Troponin I (Hs-cTnI) and -T (Hs-cTnT) are biomarkers for myocardial injury. Cardiac troponins are measured in plasma as ng/L. Change in cardiac troponins (4 hours after cardioversion - pre-cardioversion) will be compared between room air and hyperoxia.

    Change measured from 2 hours before and 4 hours after cardioversion

  • Defibrillator Efficiency: Proportion of patients in sinus rhythm four hours post cardioversion

    Proportion of patients in sinus rhythm four hours post cardioversion

    Heart rhythm measured four hours after cardioversion

Secondary Outcomes (2)

  • Cardiac rhythm and change in biomarkers

    Biomarkers will be measured within 2 hours before, 4 hours after and 3 months after cardioversion. ECG will be recorded after 1 minute, 30 minutes and four hours after cardioversion.

  • Echocardiography

    Performed at baseline, 2-4 hours after and 3 months following cardioversion

Study Arms (4)

1 ("Standard": Oxygen / LIFEPAK 20)

EXPERIMENTAL

1. Intervention: Cardioversion with a biphasic truncated exponential waveform 2. Intervention: Hyperoxia during cardioversion

Device: Cardioversion with a biphasic truncated exponential waveformProcedure: Hyperoxia during cardioversion

2 (room air / LIFEPAK 20)

ACTIVE COMPARATOR

1. Intervention: Cardioversion with a biphasic truncated exponential waveform 2. Intervention: Normoxia during cardioversion

Procedure: Normoxia during cardioversionDevice: Cardioversion with a biphasic truncated exponential waveform

3 (Oxygen / Schiller Defigard 5000)

ACTIVE COMPARATOR

1. Intervention: Cardioversion with a pulsed biphasic waveform 2. Intervention: Hyperoxia during cardioversion

Device: Cardioversion with a pulsed biphasic waveformProcedure: Hyperoxia during cardioversion

4 (Room air / Schiller Defigard 5000)

ACTIVE COMPARATOR

1. Intervention: Cardioversion with a pulsed biphasic waveform 2. Intervention: Normoxia during cardioversion

Device: Cardioversion with a pulsed biphasic waveformProcedure: Normoxia during cardioversion

Interventions

Cardioversion with a pulsed biphasic waveformDEVICE

Cardioversion will be performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard 5000) with an energy setting of 90J, 120J, 150J, 200J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.

Also known as: Schiller Defigard 5000 (SCHILLER AG, Baar, Switzerland)
3 (Oxygen / Schiller Defigard 5000)4 (Room air / Schiller Defigard 5000)
Normoxia during cardioversionPROCEDURE

Patients will be treated with room air with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal room air with a flow of 3 L/minute for 30 minutes following cardioversion

Also known as: room air during cardioversion
2 (room air / LIFEPAK 20)4 (Room air / Schiller Defigard 5000)
Cardioversion with a biphasic truncated exponential waveformDEVICE

Cardioversion will be performed by a biphasic truncated exponential waveform (LIFEPAK 20), with a energy setting of 100J, 150J, 200J, 250J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.

Also known as: LIFEPAK 20, Physio Control Inc., Redmond, WA, USA
1 ("Standard": Oxygen / LIFEPAK 20)2 (room air / LIFEPAK 20)
Hyperoxia during cardioversionPROCEDURE

Patients will be treated with 100% oxygen with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal 100% oxygen with a flow of 3 L/minute for 30 minutes following cardioversion

Also known as: 100% oxygen during cardioversion
1 ("Standard": Oxygen / LIFEPAK 20)3 (Oxygen / Schiller Defigard 5000)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atrial fibrillation or -flutter

You may not qualify if:

  • Patients \<18 years of age
  • Pregnancy
  • Haemodynamically unstable patients
  • Other arrhythmias
  • Untreated hyperthyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Randers Regional Hospital

Randers, Central Jutland, 8970, Denmark

Location

Related Publications (2)

  • Lauridsen KG, Schmidt AS, Adelborg K, Bach L, Hornung N, Jepsen SM, Deakin CD, Rickers H, Lofgren B. Effects of hyperoxia on myocardial injury following cardioversion-A randomized clinical trial. Am Heart J. 2018 Feb;196:97-104. doi: 10.1016/j.ahj.2017.10.006. Epub 2017 Oct 14.

    PMID: 29421020DERIVED

  • Schmidt AS, Lauridsen KG, Adelborg K, Torp P, Bach LF, Jepsen SM, Hornung N, Deakin CD, Rickers H, Lofgren B. Cardioversion Efficacy Using Pulsed Biphasic or Biphasic Truncated Exponential Waveforms: A Randomized Clinical Trial. J Am Heart Assoc. 2017 Mar 8;6(3):e004853. doi: 10.1161/JAHA.116.004853.

    PMID: 28275066DERIVED

MeSH Terms

Conditions

Atrial FibrillationAtrial Flutter

Interventions

Electric Countershock

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeutics

Study Officials

  • Bo Løfgren, MD, PhD

    Randers Regional Hospital

    STUDY DIRECTOR

  • Kasper G. Lauridsen, MB

    Randers Regional Hospital

    PRINCIPAL INVESTIGATOR

  • Anders S. Schmidt, MB

    Randers Regional Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 18, 2014

First Posted

December 15, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

January 1, 2016

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

DK(1)