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Dual Versus Single Shock for Cardioversion of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03943693
Recruitment Status : Active, not recruiting
First Posted : May 9, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

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 Intervention/treatment Phase
Atrial Fibrillation Device: Double shock Device: Single shock 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
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 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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 <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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943693


Locations
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United States, Oklahoma
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73105
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Deborah Lockwood, MD University of Oklahoma
Publications of Results:
Other Publications:
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03943693    
Other Study ID Numbers: 10276
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes