Clinical Trial Comparing Devices Used for Cardioversion of Atrial Fibrillation

Part of paid clinical trials in Falls Church, Virginia.

Sponsor
Inova Health Care Services
Study ID
NCT05992623
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jul 21, 2023
Status verified
Sep 2025
Primary completion
Aug 14, 2024
Completion
Dec 11, 2024

Study Design

Enrollment
546 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillator
    Participants receiving Direct Current Cardioversion (DCCV) using full output Rectilinear Biphasic Waveform (RBW) shocks from a Zoll defibrillator (200 Joules) up to 2 shocks.
  • Active Comparator: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillator
    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.
  • Active Comparator: Zoll defibrillator waveform used after unsuccessful second full output shock.
    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.
  • Active Comparator: Lifepak defibrillator waveform used after unsuccessful second full output 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.

Primary Outcome Measure

The Number of Participants in Normal Sinus Rhythm (NSR) by ECG After the First DCCV Shock [ Time Frame: At least 1 minute after shock delivery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Inova Health SystemFalls ChurchVirginia22042-

Find similar trials in Falls Church, VA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Inova Health System· Falls Church, VA

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