Status:
COMPLETED
Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
Lead Sponsor:
Inova Health Care Services
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this single center, investigator initiated, open label prospective randomized controlled trial is to compare the efficacy of a single 200J RBW shock and a single 360J BTE shock. The second...
Detailed Description
Data will be derived from approximately 560 patients arriving to Inova sites of care in Atrial Fibrillation (AF) scheduled to undergo either Atrial Fibrillation ablation with expected Direct Current C...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area
Exclusion
- Participants who are receiving any other investigational agents.
- Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patients with arrhythmias other than AF
- Patients with hemodynamically unstable AF
- Patients with untreated hyperthyroidism
- Patients with known or suspected pregnancy
- Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi
Key Trial Info
Start Date :
July 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT05992623
Start Date
July 21 2023
End Date
December 11 2024
Last Update
September 22 2025
Active Locations (1)
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1
Inova Health System
Falls Church, Virginia, United States, 22042