Single vs. Dual-DCCV in Obese Patients
Primary Purpose
Atrial Fibrillation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Direct Current Cardioversion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Ochsner Medical Center - West BankRecruiting
- Ochsner Medical CenterRecruiting
- LSU Health Sciences Center - ShreveportRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
single-DCCV group
dual-DCCV group
Arm Description
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.
Outcomes
Primary Outcome Measures
Successful return to sinus rhythm confirmed via rhythm strip ECG (regardless of duration) immediately following DCCV
Participant cardiac rhythm verified to have returned to sinus rhythm by single-lead rhythm strip ECG obtained via the defibrillator device.
Secondary Outcome Measures
Full Information
NCT ID
NCT04539158
First Posted
August 30, 2020
Last Updated
March 28, 2023
Sponsor
Dr. Daniel P Morin, MD MPH FHRS
1. Study Identification
Unique Protocol Identification Number
NCT04539158
Brief Title
Single vs. Dual-DCCV in Obese Patients
Official Title
Efficacy and Safety of Dual Direct Current Cardioversion Versus Single Direct Current Cardioversion as an Initial Treatment Strategy in Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 7, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Daniel P Morin, MD MPH FHRS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single-DCCV group
Arm Type
Active Comparator
Arm Description
Patients randomized to single-DCCV will be given a single 200J shock using the "primary" (or right anterior-left posterior) pair of pads.
Arm Title
dual-DCCV group
Arm Type
Experimental
Arm Description
Patients assigned to dual-DCCV will receive two simultaneous 200J shocks (from both the "primary" and "secondary" set of defibrillator pads), totaling 400J delivered.
Intervention Type
Device
Intervention Name(s)
Direct Current Cardioversion
Intervention Description
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 Information:
Title
Successful return to sinus rhythm confirmed via rhythm strip ECG (regardless of duration) immediately following DCCV
Description
Participant cardiac rhythm verified to have returned to sinus rhythm by single-lead rhythm strip ECG obtained via the defibrillator device.
Time Frame
0-1 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nilmo Hernandez
Phone
504-703-3265
Email
nilmo.hernandez@ochsner.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katasha Washington
Phone
504-842-8747
Email
kwashington@ochsner.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Morin, MD
Organizational Affiliation
Ochsner Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Medical Center - West Bank
City
Gretna
State/Province
Louisiana
ZIP/Postal Code
70056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilmo Hernandez, BS
Phone
504-703-3265
Email
nilmo.hernandez@ochsner.org
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nilmo Hernandez, BS
Phone
504-703-3265
Email
nilmo.hernandez@ochsner.org
First Name & Middle Initial & Last Name & Degree
Katasha Washington
Phone
504-842-8747
Email
kwashington@ochsner.org
First Name & Middle Initial & Last Name & Degree
Daniel P. Morin, MD
First Name & Middle Initial & Last Name & Degree
Joshua Aymond, MD
First Name & Middle Initial & Last Name & Degree
Michael Bernard, MD
First Name & Middle Initial & Last Name & Degree
Paul Rogers, MD
First Name & Middle Initial & Last Name & Degree
Sammy Khatib, MD
First Name & Middle Initial & Last Name & Degree
Glenn Polin, MD
Facility Name
LSU Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monicah Jepkemboi, BS
First Name & Middle Initial & Last Name & Degree
Paari Dominic, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Single vs. Dual-DCCV in Obese Patients
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