Clinical trial NCT05992623: Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation
Official title: A Pragmatic Randomized Clinical Trial Comparing Rectilinear Biphasic Waveform and Biphasic Truncated Exponential Waveform Shocks for Cardioversion of Atrial Fibrillation (Zoll vs Lifepak)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Inova Health Care Services
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will be randomized to a Zoll or Lifepak defibrillator to perform the DCCV. All shocks will be full output (200J for Zoll shocks and 360J for Lifepak shocks). Follow up will be assessment and documentation of rhythm 1 minute after the last shock is delivered. Participants who do not have first shock success will have a second full output shock ≥1 minute after the first shock. Participants who do not have success after a second full output shock will be crossed over to the other defibrillator waveform and receive up to 2 full output shocks with a minimum of 1 minute between each shock to ascertain the outcome of the immediately prior shock.
Primary purpose: TREATMENT

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 secondary objective of the study is to compare the frequency of adverse events after one or two 200J RBW or 360J BTE shocks

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 Cardioversion (DCCV) or elective stand-alone AF DCCV. Patients will be included if they are in AF prior to their procedure and are willing to sign the information sheet and comply with the research procedures. Participants will be excluded if they are in a rhythm other than AF on arrival, have not been appropriately anticoagulated with warfarin or direct oral anticoagulant, or have known left atrial appendage thrombus prior to their procedure.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area

Exclusion Criteria:

1. Participants who are receiving any other investigational agents.
2. Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
3. Patients with arrhythmias other than AF
4. Patients with hemodynamically unstable AF
5. Patients with untreated hyperthyroidism
6. Patients with known or suspected pregnancy
7. Patients without sufficient anticoagulation or a transesophageal echocardiogram or computed tomography scan documenting the absence of intracardiac thrombi

Primary outcomes:
measure: The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock
timeFrame: Up to 1 minute after shock delivered
Secondary outcomes:
Other outcomes:
Locations:
city: Falls Church
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Inova Health Care Services
name: Brett Atwater, MD
role: PRINCIPAL_INVESTIGATOR
References: