RECRUITING

Single vs. Dual-DCCV in Obese Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy and Safety of Dual Direct Current Cardioversion Versus Single Direct Current Cardioversion as an Initial Treatment Strategy in Obese Patients

Quick Facts

Study Start:2020-08-07
Study Completion:2023-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04539158

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age
  2. * Atrial fibrillation (paroxysmal, persistent, and long-standing persistent)
  3. * 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
  4. * Adequate anticoagulation at the time of the cardioversion (one of the following):
  5. * Coumadin with an INR \>2
  6. * Direct oral anticoagulants (apixaban, dabigatran, rivaroxaban, or edoxaban)
  7. * Subcutaneous low molecular-weight heparin or IV unfractionated heparin
  8. * 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
  9. * Able to maintain uninterrupted therapeutic anticoagulation after cardioversion, for at least one month
  1. * Contraindication to cardioversion
  2. * Not on adequate anticoagulation
  3. * Emergent cardioversion
  4. * Incarceration
  5. * Pregnancy

Contacts and Locations

Study Contact

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

Principal Investigator

Daniel P Morin, MD
PRINCIPAL_INVESTIGATOR
Ochsner Health System

Study Locations (Sites)

Ochsner Medical Center - West Bank
Gretna, Louisiana, 70056
United States
Ochsner Medical Center
New Orleans, Louisiana, 70121
United States
LSU Health Sciences Center - Shreveport
Shreveport, Louisiana, 71103
United States

Collaborators and Investigators

Sponsor: Dr. Daniel P Morin, MD MPH FHRS

  • Daniel P Morin, MD, PRINCIPAL_INVESTIGATOR, Ochsner Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-07
Study Completion Date2023-07-31

Study Record Updates

Study Start Date2020-08-07
Study Completion Date2023-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Fibrillation