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Single vs. Dual-DCCV in Obese Patients

NCT04539158 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-30

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Dr. Daniel P Morin, MD MPH FHRS

    lead OTHER

Principal Investigators

  • Daniel P Morin, MD · Ochsner Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2023-07-01
Completion
2023-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04539158 on ClinicalTrials.gov