Comparison of High Versus Escalating Shocks in Cardioverting Atrial Fibrillation

NCT02923414 | Completed DMC

• 1 other identifier: 52187
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is the most common heart rhythm disorder. For patients suffering atrial fibrillation direct current cardioversion is performed to reduce patients symptoms and prevent disease progression. The optimal energy selection for biphasic cardioversion is unknown. We aim to investigate the efficiency and safety of a high energy shock protocol (360 J) versus a standard escalating shock protocol (125-150-200 J) in cardioversion of atrial fibrillation.

Conditions

Atrial Fibrillation

Keywords

Cardioversion

Outcome Measures

Primary Outcomes (1)

• Efficacy: Successful cardioversion

  Successful cardioversion is defined as the proportion of patients in sinus rhythm one minute after cardioversion or cardioversion attempt (to a maximum of the 3 shocks in the protocol).

  One minute following cardioversion

Secondary Outcomes (5)

• Efficacy: First shock success

  Following first cardioversion attempt

• Safety: Arrhythmic events and ECG-changes following cardioversion

  Within four hours following cardioversion (until discharge)

• Safety: Skin-discomfort, skin burns or itching

  Two hours after cardioversion

• Safety: Troponin I level changes following cardioversion

  Four hours after cardioversion

• Safety: Echocardiographic evaluation following cardioversion

  Two hours after cardioversion

Study Arms (2)

Standard escalating shocks

ACTIVE COMPARATOR

Patients will be randomized to a standard escalating shock protocol using the energy settings: 125, 150, 200 J. All cardioversion attempts will be performed using LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

Device: Standard escalating shocks

High energy shocks

ACTIVE COMPARATOR

Patients will be randomized to a high energy shock protocol using the energy settings: 360, 360, 360 J. All cardioversion attempts will be performed using LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

Device: High energy shock protocol

Interventions

Standard escalating shocks DEVICE

125 J, 150 J, 200 J

Also known as: LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

Standard escalating shocks

High energy shock protocol DEVICE

360 J, 360 J, 360 J.

Also known as: LIFEPAK 20, Physio-Control Inc., Redmond, WA, USA

High energy shocks

Eligibility Criteria

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

You may qualify if:

• \>18 years of age, scheduled for cardioversion of atrial fibrillation. Patients with atrial fibrillation for ≤48 hours may be cardioverted immediately. Patients with atrial fibrillation for \>48 hours will be required to have a documented weekly international normalized ratio (INR) ≥2.0 (including within 48 hours of cardioversion) or treatment with non-vitamin K oral anticoagulant for three weeks or longer. Alternatively, a transoesophageal echocardiogram documenting absence of intracardiac thrombi is accepted and cardioversion can be performed on treatment with low molecular weight heparin.

You may not qualify if:

• Pregnancy, haemodynamically unstable atrial fibrillation, other arrhythmias than atrial fibrillation, untreated hyperthyroidism

Sponsors & Collaborators

• University of Aarhus: lead
• Randers Regional Hospital: collaborator

Study Sites (1)

Randers Regional Hospital

Randers, 8930, Denmark

Location

Related Publications (8)

• Lown B. Electrical reversion of cardiac arrhythmias. Br Heart J. 1967 Jul;29(4):469-89. doi: 10.1136/hrt.29.4.469. No abstract available.

  PMID: 6029120 BACKGROUND

• Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.

  PMID: 27567408 BACKGROUND

• January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available.

  PMID: 24682347 BACKGROUND

• Deakin CD, Nolan JP, Sunde K, Koster RW. European Resuscitation Council Guidelines for Resuscitation 2010 Section 3. Electrical therapies: automated external defibrillators, defibrillation, cardioversion and pacing. Resuscitation. 2010 Oct;81(10):1293-304. doi: 10.1016/j.resuscitation.2010.08.008. No abstract available.

  PMID: 20956050 BACKGROUND

• Glover BM, Walsh SJ, McCann CJ, Moore MJ, Manoharan G, Dalzell GW, McAllister A, McClements B, McEneaney DJ, Trouton TG, Mathew TP, Adgey AA. Biphasic energy selection for transthoracic cardioversion of atrial fibrillation. The BEST AF Trial. Heart. 2008 Jul;94(7):884-7. doi: 10.1136/hrt.2007.120782. Epub 2007 Jun 25.

  PMID: 17591649 BACKGROUND

• Ambler JJ, Deakin CD. A randomized controlled trial of efficacy and ST change following use of the Welch-Allyn MRL PIC biphasic waveform versus damped sine monophasic waveform for external DC cardioversion. Resuscitation. 2006 Nov;71(2):146-51. doi: 10.1016/j.resuscitation.2006.03.017. Epub 2006 Sep 20.

  PMID: 16987583 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

• Deakin CD, Ambler JJ. Post-shock myocardial stunning: a prospective randomised double-blind comparison of monophasic and biphasic waveforms. Resuscitation. 2006 Mar;68(3):329-33. doi: 10.1016/j.resuscitation.2005.07.021. Epub 2005 Dec 27.

  PMID: 16378672 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Bo Løfgren, MD, PhD

  Randers Regional Hospital

  STUDY DIRECTOR

• Anders S Schmidt, MB

  Randers Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 4, 2016
• Study Start: September 28, 2016
• Primary Completion: March 8, 2019
• Study Completion: March 8, 2019
• Last Updated: March 22, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)