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 @ 4:15 AM
Ignite Modification Date:
2025-12-25 @ 4:15 AM
NCT ID:
NCT05247320
Eligibility Criteria:
Inclusion Criteria:
1. Adults age 18 years and older
2. Eligible for the use of elective intravenous sotalol loading to treat atrial arrhythmias, per the treating clinician
3. IV sotalol infusion started for the treatment of atrial arrhythmias, in the setting of initiation or dose titration of chronic sotalol therapy
4. Elective hospital admission primarily for loading with intravenous sotalol with/without cardioversion, with no other planned therapy or procedures
Exclusion Criteria:
1. Study materials not available in the subject's preferred language.
2. Patients undergoing treatment for active concomitant ventricular arrhythmias
3. Standard exclusions for elective sotalol use (at the time of initiation):
* Heart rate \< 40 bpm or 2nd/3rd degree AV block without pacemaker
* QTc ≥ 450 in absence of bundle branch block (≥ 500 in the presence of a bundle branch block)
* Severe left ventricular hypertrophy (thickness \>1.5 cm)
4. Patients who were previously intolerant to antiarrhythmic class III therapy
5. Patients missing key data elements in their electronic health record (for retrospective subjects only).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05247320
Study Brief:
Protocol Section:
NCT05247320