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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
New Zealand
Wellington Regional Hospital
RECRUITING
Wellington
Contact Information
Primary
Allan M Plant, FRACP
allanmplant@gmail.com
+64274114001
Backup
Darren Hooks, FRACP
darren.hooks@ccdhb.org.nz
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Active_comparator: 360J LifePak Monitor/Defibrillator
The standardised cardioversion protocol below performed with a 360J shock from a Lifepak Monitor/Defibrillator.~1. First shock with anteroposterior pad configuration~2. In event of failure of the above, a second shock with anterolateral pad configuration~3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure
Active_comparator: 200J Philips HeartStart MRx Monitor/Defibrillator
The standardised cardioversion protocol below performed with a 200J shock from a Philips HeartStart MRx Monitor/Defibrillator.~1. First shock with anteroposterior pad configuration~2. In event of failure of the above, a second shock with anterolateral pad configuration~3. In event of failure of the above, a third shock with anteroposterior pad configuration + manual pad pressure~4. The addition of a fourth 'rescue' shock at 360J using the LifePak Monitor/Defibrillator with pads in the anteroposterior configuration in the event of the first three steps failing to cardiovert to sinus rhythm
Related Therapeutic Areas
Sponsors
Leads: Wellington Hospital

This content was sourced from clinicaltrials.gov