Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539158
Status:
RECRUITING
Last Update Posted:
2023-03-30
First Post:
2020-08-30
Brief Title:
Single vs Dual-DCCV in Obese Patients
Sponsor:
Dr Daniel P Morin MD MPH FHRS
Organization:
Ochsner Health System
Study Overview
Official Title:
Efficacy and Safety of Dual Direct Current Cardioversion Versus Single Direct Current Cardioversion as an Initial Treatment Strategy in Obese Patients
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 kgm2 Failure to achieve sinus rhythm then necessitates additional shocks which still may ultimately fail to terminate the patients 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 AssociationAmerican College of CardiologyHeart 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
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 AssociationAmerican College of CardiologyHeart 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
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 11 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None