Recruiting

Single vs. Dual-DCCV

Sponsor:

Dr. Daniel P Morin, MD MPH FHRS

Code:

NCT04539158

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Direct Current Cardioversion

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT04539158

Start date

Aug 7, 2020

Status verified date

Mar, 2023

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Jul 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

  • Successful return to sinus rhythm confirmed via rhythm strip ECG (regardless of duration) immediately following DCCV [ Time Frame: 0-1 hours ]

Central Contacts and Locations

Central contacts

Nilmo Hernandez

504-703-3265nilmo.hernandez@ochsner.org

Katasha Washington

504-842-8747kwashington@ochsner.org

Locations

Ochsner Medical Center - West Bank

Recruiting

Gretna, Louisiana, United States, 70056

Contacts

Nilmo Hernandez, BS

504-703-3265nilmo.hernandez@ochsner.org

Ochsner Medical Center

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Nilmo Hernandez, BS

504-703-3265nilmo.hernandez@ochsner.org

Katasha Washington

504-842-8747kwashington@ochsner.org

Principal Investigator:

Daniel P. Morin, MD

LSU Health Sciences Center - Shreveport

Recruiting

Shreveport, Louisiana, United States, 71103

Principal Investigator:

Paari Dominic, MD

More Information

Sponsor

Dr. Daniel P Morin, MD MPH FHRS

Last update posted

Mar 30, 2023

Last verified

Mar, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Daniel P Morin, MD MPH FHRS on 2023-03-30.