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NCT Number: NCT05903170

Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation

The goal of this clinical trial is to compare the efficacy of a maximum output shock for cardioverting atrial fibrillation between two commonly used defibrillators in New Zealand . These machines have different maximum energy outputs, and to date no head-to-head comparison cardioverting atrial fibrillation between the two has been undertaken.

The main question it aims to answer is whether either device is more likely to cardiovert patients referred for atrial fibrillation.

Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Participants in each arm will undergo up to three shocks at the energy-level to which they have been randomized, using a standardized procedure. For participants randomized to the lower energy level who fail to return to normal rhythm after three shocks, they will be given a fourth shock at the higher energy level.

All participants will then be asked to undertake a blood test the day following the cardioversion, and receive a follow up phone call. These are to ensure there is no difference in the safety of the procedure between the two energy levels. It is worth noting that these two components of the study (the blood test and phone call) are the only additional time commitment that is expected to be involved if you choose to participate in the study.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellington Regional Hospital

Wellington, Wellington Region, 6012, New Zealand

Location status: Recruiting

Location contact

Allan Plant, MBChB

CONTACT

[email protected]

0274114001

Darren Hooks, MBChB, PhD

CONTACT

[email protected]

About this study

Atrial fibrillation is the world's most common arrhythmia, with an incidence that is increasing in Western countries. One-in-four adults will experience atrial fibrillation at some point in their life.

Strategies for the management of atrial fibrillation include rate control, prophylaxis against stroke, lifestyle modification, and restoration of sinus rhythm through medical or electrical cardioversion. Electrical cardioversion for the restoration of sinus rhythm was first described by Lown and colleagues in 1962, and has undergone a number of procedural advances in the intervening six decades. Chief amongst these was a transition from cardioverting using monophasic to biphasic waveforms, something unequivocally demonstrated to increase cardioversion success, with lower energy, current, and less skin and muscle damage than monophasic devices. Yet the majority of the data which continues to guide cardioversion is derived from the era of monophasic therapy.

Data from cardioversion with monophasic waveforms suggests that the use of higher initial shock energy is associated with higher first shock success, fewer shocks, and lower levels of skeletal muscle injury, with no increase in troponin to suggest greater cardiac injury. Likewise, studies of shock energy using biphasic devices have demonstrated benefit of maximum fixed shock energy. However, whilst the energy of a defibrillator remains entrenched in the descriptive vocabulary of cardioversion for atrial fibrillation, it is the flow of current across the myocardium that achieves cardioversion, and resuscitation guidelines have previously recommended a switch to the more physiologic current-based description.

Different defibrillators deliver different currents at the same energy setting based on the capacitance of the device. As such, manufacturers of defibrillators recommend different energy levels for cardioverting atrial fibrillation with some standard biphasic defibrillators (Philips HeartStart MRx Monitor/Defibrillator) unable to deliver higher than 200J energy, while some (Lifepak 15 Monitor/Defibrillator) extend to 360J. No studies have compared initial 200J vs. 360J shock energies between these devices for cardioverting persistent atrial fibrillation.

This study is a single centre randomized non-blinded study of the effectiveness of 200J vs. 360J fixed output biphasic electrical cardioversion in patients undergoing electrical cardioversion of persistent atrial fibrillation. The study hypothesis is that cardioversion with shock energy fixed to 360J delivered by a LifePak Monitor/Defibrillator is more efficacious than a 200J delivered by a Philips HeartStart MRx Monitor/Defibrillator, without worsening safety outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18
  • Patients undergoing either elective outpatient or non-emergent inpatient cardioversion for atrial fibrillation
  • Eligible for anticoagulation
  • Reliably anticoagulated for ≥three weeks prior to cardioversion, AF onset within 48hrs of cardioversion, or left atrial thrombus excluded on transoesophageal echocardiogram
  • Able to consent to cardioversion, and study participation

Exclusion criteria

  • Contraindication to anticoagulation
  • Atrial flutter
  • Emergent cardioversion
  • Implantable cardiac device (PPM or ICD)
  • Unable to consent to cardioversion and/or study participation
  • Pregnancy

Treatment and study plan

360J LifePak Monitor/Defibrillator

Device

The LifePak Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 360J.

200J Philips HeartStart MRx Monitor/Defibrillator

Device

The Philips HeartStart MRx Monitor/Defibrillator is a commonly-used defibrillator in New Zealand hospitals for cardioverting atrial fibrillation. It delivers a biphasic waveform shock with a titratable maximum energy of 200J.

Primary outcomes

  1. Cardioversion efficacy

    Time frame: During Procedure (1 Hour)

    Percentage of patients successfully cardioverted to sinus rhythm

Secondary outcomes

  1. Shock number

    Time frame: During Procedure (1 Hour)

    Number of shocks required to cardiovert to sinus rhythm

  2. Cumulative energy

    Time frame: During Procedure (1 Hour)

    Total energy delivered during procedure

Other outcomes

  1. Safety outcome: skin erythema

    Time frame: 2 hours after procedure

    Proportion of patients with documented skin erythema at discharge

  2. Safety outcome: pain score

    Time frame: 2 hours after procedure

    Average pain score on a 10 point numerical rating scale from 0 (no pain) to 10 (severe pain)

  3. Safety outcome: troponin elevation

    Time frame: 24 hours after procedure

    Proportion of patients with a significant troponin elevation (defined as a troponin greater the ULN and ≥50% increase from baseline)

  4. Safety outcome: troponin change from baseline

    Time frame: 24 hours after procedure

    Average change in troponin from baseline

  5. Safety outcome: creatine kinase change from baseline

    Time frame: 24 hours after procedure

    Average change in creatinine kinase from baseline

  6. Safety outcome: other

    Time frame: 2 hours after procedure

    Any other clinically-significant event requiring change in management (need for temporary pacing / BP support / admission due to complications)

Study contacts

Contact information is provided by the study sponsor or research team.

Allan M Plant, FRACP

CONTACT

[email protected]

+64274114001

Darren Hooks, FRACP

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Wellington Hospital

Other Gov

Registry information

Official study title

A Randomised Trial of Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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