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Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zoll external defibrillator
Lifepak external defibrillator
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area Exclusion Criteria: 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

Sites / Locations

  • Inova Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator

Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator

Zoll defibrillator waveform used after unsuccessful second full output shock.

Lifepak defibrillator waveform used after unsuccessful second full output shock.

Arm Description

Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.

Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.

Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak 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.

Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
August 11, 2023
Sponsor
Inova Health Care Services
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1. Study Identification

Unique Protocol Identification Number
NCT05992623
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 21, 2023 (Actual)
Primary Completion Date
May 23, 2024 (Anticipated)
Study Completion Date
November 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator
Arm Type
Active Comparator
Arm Description
Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.
Arm Title
Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator
Arm Type
Active Comparator
Arm Description
Participants receiving Direct Current Cardioversion (DCCV) using full output Biphasic Truncated Exponential Waveform (BTE) shocks from a Physiocontrol/Medtronic Lifepak defibrillator (360 Joules) up to 2 shocks.
Arm Title
Zoll defibrillator waveform used after unsuccessful second full output shock.
Arm Type
Active Comparator
Arm Description
Participants who received first shock via Zoll that do not have success after a second full output shock will be crossed over to the Lifepak 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.
Arm Title
Lifepak defibrillator waveform used after unsuccessful second full output shock.
Arm Type
Active Comparator
Arm Description
Participants who received first shock via Lifepak that do not have success after a second full output shock will be crossed over to the Zoll 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.
Intervention Type
Device
Intervention Name(s)
Zoll external defibrillator
Intervention Description
Patients with AF will be randomized to receive a full output synchronized 200J shock using a RBW waveform from a Zoll defibrillator
Intervention Type
Device
Intervention Name(s)
Lifepak external defibrillator
Intervention Description
Patients with AF will be randomized to receive a full output synchronized 360J shock using a BTE waveform from a Lifepak defibrillator
Primary Outcome Measure Information:
Title
The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock
Description
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
Time Frame
Up to 1 minute after shock delivered

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Atwater, MD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

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