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Single vs. Dual-DCCV in Obese Patients

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ClinicalTrials.gov Identifier: NCT04539158
Recruitment Status : Recruiting
First Posted : September 4, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Daniel P Morin, MD MPH FHRS, Ochsner Health System

Brief Summary:

Currently, the usual initial strategy for direct current cardioversion (DCCV) typically involves delivering 200J of electricity between two pads placed in the anterior and posterior positions (i.e., one on the chest and one on the back). However, this technique may be less likely to result in successful cardioversion in obese patients (BMI ≥30 kg/m2). Failure to achieve sinus rhythm then necessitates additional shocks, which still may ultimately fail to terminate the patient's atrial fibrillation, thereby increasing the likelihood of adverse events from multiple cardioversion attempts

"Dual-DCCV" is a technique in which four pads are used to deliver two simultaneous shocks of 200J, totaling 400J. Guidelines published by the American Heart Association/American College of Cardiology/Heart Rhythm Society and the European Society of Cardiology provide only general guidance regarding the appropriate technique and energy selection in patients undergoing cardioversion, with no specific recommendations pertaining to dual-DCCV or obese patients.

This study aims to assess the safety and efficacy of dual-DCCV as an initial treatment strategy, compared to standard single-DCCV, in the obese population.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Direct Current Cardioversion Not Applicable

Detailed Description:

Patients with sustained atrial fibrillation and obesity who are scheduled for a cardioversion for atrial fibrillation will provide written informed consent prior to starting the procedure. Patients will be randomly assigned in a 1:1 fashion to either single-DCCV or dual-DCCV treatment.

All patients will have 4 defibrillation pads placed: two pads placed in the right infraclavicular region and left flank region, plus two pads placed in the left infraclavicular and right flank region.

All patients will receive moderate sedation immediately prior to and during cardioversion.

Patients randomized to single-DCCV will be given a single 200J shock using the "primary" (or right anterior-left posterior) pair of pads. Patients assigned to dual-DCCV will receive two simultaneous 200J shocks (from both the "primary" and "secondary" set of defibrillator pads), totaling 400J delivered.

Patients in the single-DCCV group whose initial shock fails to restore normal sinus rhythm will be crossed over to the dual-DCCV group. Patients in the dual-DCCV group will receive up to three attempts at DCCV, as needed, at the discretion of the attending electrophysiologist.

One hour after cardioversion is completed, patients will be asked if they experienced any chest discomfort related to cardioversion and, if applicable, will rate their chest discomfort using a pain scale from 0-10.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Patients will be randomly assigned in a 1:1 fashion to either single-DCCV or dual-DCCV treatment.

All patients will have 4 defibrillation pads placed: two pads placed in the right infraclavicular and left flank regions, plus two pads placed in the left infraclavicular and right flank regions.

Patients randomized to single-DCCV will receive a single 200J shock using the "primary" (or right anterior-left posterior) pair of pads. Patients assigned to dual-DCCV will receive two simultaneous 200J shocks (from both the "primary" and "secondary" set of defibrillator pads), totaling 400J delivered.

Patients in the single-DCCV group whose initial shock fails to restore normal sinus rhythm will be crossed over to the dual-DCCV group. Patients in the dual-DCCV group will receive up to three attempts at DCCV, as needed, at the discretion of the attending electrophysiologist.

Masking: Single (Participant)
Masking Description: All patients will have 4 defibrillation pads placed: two pads placed in the right infraclavicular and left flank regions, plus two pads placed in the left infraclavicular and right flank regions. Patients will not be told which arm they are randomized to during the procedure.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Dual Direct Current Cardioversion Versus Single Direct Current Cardioversion as an Initial Treatment Strategy in Obese Patients
Actual Study Start Date : August 7, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: single-DCCV group
Patients randomized to single-DCCV will be given a single 200J shock using the "primary" (or right anterior-left posterior) pair of pads.
Device: Direct Current Cardioversion
The patient is sedated and shocked using an external defibrillator to terminate the arrhythmia and restore a normal intrinsic rhythm (i.e., normal sinus rhythm).

Experimental: dual-DCCV group
Patients assigned to dual-DCCV will receive two simultaneous 200J shocks (from both the "primary" and "secondary" set of defibrillator pads), totaling 400J delivered.
Device: Direct Current Cardioversion
The patient is sedated and shocked using an external defibrillator to terminate the arrhythmia and restore a normal intrinsic rhythm (i.e., normal sinus rhythm).




Primary Outcome Measures :
  1. Successful return to sinus rhythm confirmed via rhythm strip ECG (regardless of duration) immediately following DCCV [ Time Frame: 0-1 hours ]
    Participant cardiac rhythm verified to have returned to sinus rhythm by single-lead rhythm strip ECG obtained via the defibrillator device.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age
  • Atrial fibrillation (paroxysmal, persistent, and long-standing persistent)
  • Obesity (defined as body mass index [BMI] ≥35 kg/m2). Of note, our current institutional protocol uses weight >250 lbs as an indication for dual-DCCV. An average height of 70 inches equates to BMI ~35 kg/m2
  • Adequate anticoagulation at the time of the cardioversion (one of the following):

    • Coumadin with an INR >2
    • Direct oral anticoagulants (apixaban, dabigatran, rivaroxaban, or edoxaban)
    • Subcutaneous low molecular-weight heparin or IV unfractionated heparin
  • If the duration of atrial fibrillation is >48 hours (or unknown): trans-esophageal echocardiography (TEE) performed prior to cardioversion to document the absence of a left atrial thrombus, or continuous therapeutic anticoagulation for a minimum of 3 weeks prior to cardioversion
  • Able to maintain uninterrupted therapeutic anticoagulation after cardioversion, for at least one month

Exclusion Criteria:

  • Contraindication to cardioversion
  • Not on adequate anticoagulation
  • Emergent cardioversion
  • Incarceration
  • Pregnancy

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): NCT04539158


Contacts
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Contact: Nilmo Hernandez 504-703-3265 nilmo.hernandez@ochsner.org
Contact: Katasha Washington 504-842-8747 kwashington@ochsner.org

Locations
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United States, Louisiana
Ochsner Medical Center - West Bank Recruiting
Gretna, Louisiana, United States, 70056
Contact: Nilmo Hernandez, BS    504-703-3265    nilmo.hernandez@ochsner.org   
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Nilmo Hernandez, BS    504-703-3265    nilmo.hernandez@ochsner.org   
Contact: Katasha Washington    504-842-8747    kwashington@ochsner.org   
Principal Investigator: Daniel P. Morin, MD         
Sub-Investigator: Joshua Aymond, MD         
Sub-Investigator: Michael Bernard, MD         
Sub-Investigator: Paul Rogers, MD         
Sub-Investigator: Sammy Khatib, MD         
Sub-Investigator: Glenn Polin, MD         
LSU Health Sciences Center - Shreveport Recruiting
Shreveport, Louisiana, United States, 71103
Contact: Monicah Jepkemboi, BS         
Principal Investigator: Paari Dominic, MD         
Sponsors and Collaborators
Dr. Daniel P Morin, MD MPH FHRS
Investigators
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Principal Investigator: Daniel P Morin, MD Ochsner Health System
Publications:

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Responsible Party: Dr. Daniel P Morin, MD MPH FHRS, Medical Director of Cardiovascular Research, Ochsner Health System
ClinicalTrials.gov Identifier: NCT04539158    
Other Study ID Numbers: 2020.048
First Posted: September 4, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
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.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes