Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04539158
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04539158
Study Brief:
Protocol Section:
NCT04539158