Dual Versus Single Shock for Cardioversion of Atrial Fibrillation

NCT03943693 | Terminated Phase 4 FDA Device

• 1 other identifier: 10276
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to investigate the immediate success rate (rate of termination of atrial fibrillation) of dual shock cardioversion compared with standard single shock cardioversion in patients with baseline characteristics adversely influencing successful cardioversion. Baseline characteristics known to reduce the success rate of single shock cardioversion include: increased body mass index (BMI), chronic obstructive pulmonary disease, sleep apnea, enlarged left atrium, longer duration of atrial fibrillation and use of amiodarone.

Conditions

Atrial Fibrillation

Keywords

Cardioversion

Outcome Measures

Primary Outcomes (1)

• Cardioversion to sinus rhythm

  Successful termination of atrial fibrillation after initial DCCV. Successful = cardioversion = immediate termination of atrial fibrillation

  Immediately following cardioversion

Secondary Outcomes (4)

• Maintenance of normal sinus rhythm at one hour post cardioversion

  Within 24 hours

• Presence of symptomatic skin burn

  Immediately following cardioversion

• Thromboembolic complications

  Within 24 hours

• Ventricular arrhythmias requiring additional shock therapy

  Immediately following cardioversion

Study Arms (2)

Single Shock Group

ACTIVE COMPARATOR

Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only.

Device: Single shock

Double Shock Group

ACTIVE COMPARATOR

Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized.

Device: Double shock

Interventions

Double shock DEVICE

Patients randomized to the dual shock group will have two near-simultaneous 200-Joule shocks delivered through the two sets of pads (antero-posterior position and right infraclavicular-axillary position). The first of these shocks will be synchronized. If the first attempt with this approach fails to terminate atrial fibrillation a second attempt will be made using the same approach. If the second attempt fails the dual shock approach will be considered to have failed and further treatment will be determined by the primary team/attending cardiologist.

Double Shock Group

Single shock DEVICE

Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only. A repeat attempt will be made using the same approach if the initial shock fails. If the second attempt fails, the single shock approach will be considered to have failed. Patients will be crossed over to dual shock therapy while under the same sedation episode. For cross-over patients, two near-simultaneous 200-Joule shocks will be delivered through the two sets of pads already in position. If this fails further treatment will be determined by the primary team/attending cardiologist.

Single Shock Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatient or inpatients with atrial fibrillation sent for elective direct current cardioversion (DCCV) with at least 1 of the following risk factors will be included:
• BMI \>30
• History of Chronic Obstructive Pulmonary Disease/emphysema/asthma
• Significant Valvular heart disease (at least moderate regurgitation/stenosis)
• History of Heart Failure with preserved Ejection Fraction/Heart Failure with reduced Ejection Fraction
• Cardiomyopathy with ejection fraction \<40%
• Left atrium anterior-posterio (AP) dimension \>4.5cm
• Presence of Left ventricular hypertrophy (≥1.1cm septal/posterior wall M-mode) on transthoracic echocardiogram
• History of sleep apnea

You may not qualify if:

• Consent not obtained
• \<18 y.o.
• \>80 y.o.
• Not adequately anti-coagulated
• Patient hemodynamically unstable and DCCV required as an emergent procedure
• Prisoners or pregnant patients

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73105, United States

Location

Related Publications (6)

• Saliba W, Juratli N, Chung MK, Niebauer MJ, Erdogan O, Trohman R, Wilkoff BL, Augostini R, Mowrey KA, Nadzam GR, Tchou PJ. Higher energy synchronized external direct current cardioversion for refractory atrial fibrillation. J Am Coll Cardiol. 1999 Dec;34(7):2031-4. doi: 10.1016/s0735-1097(99)00463-5.

  PMID: 10588220 BACKGROUND

• Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.

  PMID: 24345399 RESULT

• Boriani G, Diemberger I, Biffi M, Domenichini G, Martignani C, Valzania C, Branzi A. Electrical cardioversion for persistent atrial fibrillation or atrial flutter in clinical practice: predictors of long-term outcome. Int J Clin Pract. 2007 May;61(5):748-56. doi: 10.1111/j.1742-1241.2007.01298.x.

  PMID: 17493088 RESULT

• Larsen MT, Lyngborg K, Pedersen F, Corell P. [Predictive factors of maintenance of sinus rhythm after direct current (DC) cardioversion of atrial fibrillation/atrial flutter]. Ugeskr Laeger. 2005 Sep 5;167(36):3408-12. Danish.

  PMID: 16159494 RESULT

• Vinolas X, Freire F, Romero-Menor C, Alegret JM. [Predictors of reversion to sinus rhythm previous to electrical cardioversion in patients with persistent atrial fibrillation treated with anti-arrhythmic drugs]. Med Clin (Barc). 2013 Apr 20;140(8):351-5. doi: 10.1016/j.medcli.2012.02.026. Epub 2012 Sep 14. Spanish.

  PMID: 22982132 RESULT

• Marrouche NF, Bardy GH, Frielitz HJ, Gunther J, Brachmann J. Quadruple pads approach for external cardioversion of atrial fibrillation. Pacing Clin Electrophysiol. 2001 Sep;24(9 Pt 1):1321-4. doi: 10.1046/j.1460-9592.2001.01321.x.

  PMID: 11584453 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Deborah Lockwood, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: April 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)