Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Atrial Fibrillation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04539158
Collaborators
Not Provided
Investigators
Principal Investigator: Daniel P Morin, MD Ochsner Health System