Shock Energy for Electrical Cardioversion of Persistent Atrial Fibrillation

NCT05903170 | Recruiting

• 1 other identifier: WRH DCCV
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Electrical cardioversion

Outcome Measures

Primary Outcomes (1)

• Cardioversion efficacy

  Percentage of patients successfully cardioverted to sinus rhythm

  During Procedure (1 Hour)

Secondary Outcomes (2)

• Shock number

  During Procedure (1 Hour)

• Cumulative energy

  During Procedure (1 Hour)

Other Outcomes (6)

• Safety outcome: skin erythema

  2 hours after procedure

• Safety outcome: pain score

  2 hours after procedure

• Safety outcome: troponin elevation

  24 hours after procedure

Study Arms (2)

360J LifePak Monitor/Defibrillator

ACTIVE COMPARATOR

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

Device: 360J LifePak Monitor/Defibrillator

200J Philips HeartStart MRx Monitor/Defibrillator

ACTIVE COMPARATOR

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

Device: 200J Philips HeartStart MRx Monitor/Defibrillator

Interventions

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.

360J LifePak Monitor/Defibrillator

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.

200J Philips HeartStart MRx Monitor/Defibrillator

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wellington Hospital: lead

Study Sites (1)

Wellington Regional Hospital

Wellington, Wellington Region, 6012, New Zealand

RECRUITING

Related Publications (8)

• Boos C, Thomas MD, Jones A, Clarke E, Wilbourne G, More RS. Higher energy monophasic DC cardioversion for persistent atrial fibrillation: is it time to start at 360 joules? Ann Noninvasive Electrocardiol. 2003 Apr;8(2):121-6. doi: 10.1046/j.1542-474x.2003.08205.x.

  PMID: 12848792 BACKGROUND

• ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005 Dec 13;112(24 Suppl):IV1-203. doi: 10.1161/CIRCULATIONAHA.105.166550. Epub 2005 Nov 28. No abstract available.

  PMID: 16314375 BACKGROUND

• Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.

  PMID: 31955707 BACKGROUND

• Joglar JA, Hamdan MH, Ramaswamy K, Zagrodzky JD, Sheehan CJ, Nelson LL, Andrews TC, Page RL. Initial energy for elective external cardioversion of persistent atrial fibrillation. Am J Cardiol. 2000 Aug 1;86(3):348-50. doi: 10.1016/s0002-9149(00)00932-2.

  PMID: 10922451 BACKGROUND

• Koster RW, Dorian P, Chapman FW, Schmitt PW, O'Grady SG, Walker RG. A randomized trial comparing monophasic and biphasic waveform shocks for external cardioversion of atrial fibrillation. Am Heart J. 2004 May;147(5):e20. doi: 10.1016/j.ahj.2003.10.049.

  PMID: 15131555 BACKGROUND

• Page RL, Kerber RE, Russell JK, Trouton T, Waktare J, Gallik D, Olgin JE, Ricard P, Dalzell GW, Reddy R, Lazzara R, Lee K, Carlson M, Halperin B, Bardy GH; BiCard Investigators. Biphasic versus monophasic shock waveform for conversion of atrial fibrillation: the results of an international randomized, double-blind multicenter trial. J Am Coll Cardiol. 2002 Jun 19;39(12):1956-63. doi: 10.1016/s0735-1097(02)01898-3.

  PMID: 12084594 BACKGROUND

• Schmidt AS, Lauridsen KG, Torp P, Bach LF, Rickers H, Lofgren B. Maximum-fixed energy shocks for cardioverting atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):626-631. doi: 10.1093/eurheartj/ehz585.

  PMID: 31504412 BACKGROUND

• Staerk L, Wang B, Preis SR, Larson MG, Lubitz SA, Ellinor PT, McManus DD, Ko D, Weng LC, Lunetta KL, Frost L, Benjamin EJ, Trinquart L. Lifetime risk of atrial fibrillation according to optimal, borderline, or elevated levels of risk factors: cohort study based on longitudinal data from the Framingham Heart Study. BMJ. 2018 Apr 26;361:k1453. doi: 10.1136/bmj.k1453.

  PMID: 29699974 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Defibrillators

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrodes; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Allan Plant, FRACP

  Wellington Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan M Plant, FRACP

CONTACT

+64274114001; allanmplant@gmail.com

Darren Hooks, FRACP

CONTACT

darren.hooks@ccdhb.org.nz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to undergo cardioversion with one of two defibrillators at either 200J or 360J. Randomization will occur by a random number generator, and the chance of being in either arm is 50%. 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.

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 15, 2023
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)