Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05992623
• Other study ID #: U23-04-5042
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 21, 2023
• Est. completion date: November 23, 2024

Study information

• Verified date: August 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 560
• Est. completion date: November 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Zoll external defibrillator
Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
• Lifepak external defibrillator
Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator

Locations

Country	Name	City	State
United States	Inova Health System	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock	The frequency of NSR one minute, identified by ECG, after a single full output DCCV shock is delivered by either a Zoll RBW waveform defibrillator or Lifepak BTE waveform defibrillator	Up to 1 minute after shock delivered