Clinical trial NCT03943693: Dual Versus Single Shock for Cardioversion of Atrial Fibrillation
Official title: Dual Shock Versus Single Shock Synchronized External Direct Current Cardioversion for Atrial Fibrillation - A Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Cardioversion
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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 \<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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cardioversion to sinus rhythm
timeFrame: Immediately following cardioversion
Secondary outcomes:
measure: Maintenance of normal sinus rhythm at one hour post cardioversion
timeFrame: Within 24 hours
measure: Presence of symptomatic skin burn
timeFrame: Immediately following cardioversion
measure: Thromboembolic complications
timeFrame: Within 24 hours
measure: Ventricular arrhythmias requiring additional shock therapy
timeFrame: Immediately following cardioversion
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Deborah Lockwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.