Dual Versus Single Shock for Cardioversion of Atrial Fibrillation
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03943693 Active, not recruiting May 9, 2019 April 24, 2020

study description
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.

Condition or Disease: Atrial Fibrillation
Intervention/treatment: Device: Double shock
Device: Single shock
Phase: Phase 4
Detailed Description

Patient Enrollment Patient enrollment will be open enrollment to inpatient/outpatients who
meet the inclusion/exclusion criteria listed above. This is a double-blinded study with
randomization to dual shock or standard single shock synchronized cardioversion for patients
requiring cardioversion for atrial fibrillation. Randomization will be performed using a
standard computer-based randomization system.

Cardioversion will be performed with Zoll R series Defibrillator, which was approved by the
FDA in 2017 for use as a defibrillator, with a 510K approval for use in cardioversion of
atrial arrhythmias. After obtaining consent, before sedation is administered, all patients
will have 2 pads placed in the antero-posterior pad position on the left chest (guideline
recommended position for cardioversion of atrial fibrillation) and an additional 2 pads
placed in the standard Ventricular Tachycardia/Advanced Cardiac Life Support positions, where
the anterior pad is centered over the right infraclavicular space and the apical pad is
placed over the left axilla . All patients will be sedated using propofol administered by
anesthesiology or a combination of fentanyl and midazolam administered by cardiology staff.

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.

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.

Primary Endpoint - Successful termination of atrial fibrillation after initial Direct Current
Ccardioversion (DCCV). Successful cardioversion = immediate termination of atrial
fibrillation with electrocardiographic (ECG) evidence of atrial fibrillation (AF)
termination. The physician deciding whether AF was successfully terminated will be blinded to
whether the shock was with single or dual shocks. - Partial success will be considered if
atrial fibrillation is terminated by the second attempt using the same approach. Secondary
Endpoints - Maintenance of normal sinus rhythm at one hour post cardioversion - Presence of
symptomatic skin burn (symptoms rated on a scale of 1-10) - Thromboembolic complications -
Ventricular Arrhythmias requiring additional shock therapy Documentation of Anticoagulation
All patients need to have established therapeutic anticoagulation. Either 1) Therapeutic
warfarin (with International normalized ratio (INR) >2) or therapeutic doses of apixaban,
dabigatran, rivaroxaban or edoxaban for at least 3 consecutive weeks before and with plans to
continue 4 weeks after cardioversion. 2) Therapeutic anticoagulation with intravenous heparin
or therapeutic subcutaneous enoxaparin or non-vitamin K oral anticoagulant if atrial
fibrillation episode is known to be of recent onset (<48 hours), with anticoagulation to continue for at least one week post cardioversion. 3) Sub-therapeutic or no anticoagulation preceding cardioversion, but transesophageal echocardiogram (TEE) confirming absence of intra-cardiac thrombus. Therapeutic anticoagulation should be administered just prior to cardioversion and planned to continue for at least 4 weeks post cardioversion.


study design
Study Type: Interventional
Estimated Enrollment : 100 participants
Intervention Model : Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Dual Shock Versus Single Shock Synchronized External Direct Current Cardioversion for Atrial Fibrillation - A Double-blinded Randomized Trial
Actual Study Start Date: April 2019
Estimated Primary Completion Date: December 2021
Estimated Study Completion Date: December 2021

Arms and interventions
Arm Intervention/treatment
Active Comparator: Double Shock Group
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
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.
Active Comparator: Single Shock Group
Patients randomized to single shock will then be treated initially with a 200 Joule shock through the antero-posterior pads only.
Device: Single shock
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.
outcome measures
Primary Outcome Measures: 1. Cardioversion to sinus rhythm [ Time Frame: Immediately following cardioversion ]
Successful termination of atrial fibrillation after initial DCCV. Successful = cardioversion = immediate termination of atrial fibrillation
Secondary Outcome Measures: 1. Maintenance of normal sinus rhythm at one hour post cardioversion [ Time Frame: Within 24 hours ]
2. Presence of symptomatic skin burn [ Time Frame: Immediately following cardioversion ]
Symptoms rated on a scale 1-10
3. Thromboembolic complications [ Time Frame: Within 24 hours ]
4. Ventricular arrhythmias requiring additional shock therapy [ Time Frame: Immediately following cardioversion ]

Eligibility Criteria
Ages Eligible for Study: 18 to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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 4.5cm

- Presence of Left ventricular hypertrophy (≥1.1cm septal/posterior wall M-mode) on transthoracic echocardiogram

- History of sleep apnea

Exclusion Criteria:

- Consent not obtained

- 80 y.o.

- Not adequately anti-coagulated

- Patient hemodynamically unstable and DCCV required as an emergent procedure

- Prisoners or pregnant patients


Contacts and Locations
Contacts
Locations
United States, Oklahoma University of Oklahoma Health Science Center Oklahoma City
Sponsors and Collaborators
University of Oklahoma
Investigator
Principal Investigator : Deborah Lockwood, MD University of Oklahoma
More Information
Publications of Results

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.

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.

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.

Viñolas 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.

Marrouche NF, Bardy GH, Frielitz HJ, Günther J, Brachmann J. Quadruple pads approach for external cardioversion of atrial fibrillation. Pacing Clin Electrophysiol. 2001 Sep;24(9 Pt 1):1321-4.

Other Publications

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.

Responsible Party : University of Oklahoma
ClinicalTrials.gov Identifier : NCT03943693     
Other Study ID Numbers : 10276
First Posted : May 9, 2019
Last Update Posted : April 24, 2020
Last Verified : April 2020
Individual Participant
Data (IPD) Sharing
Statement:
 
Plan to Share IPD: No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of Oklahoma: Cardioversion
Additional relevant MeSH terms :
Atrial Fibrillation