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Procedure

Cardioversion Devices for Atrial Fibrillation

N/A

Waitlist Available

Led By Brett Atwater, MD

Research Sponsored by Inova Health Care Services

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

In AF on presentation with plan for DCCV in either the Electrophysiology lab or DCCV procedure area

Must not have

Patients with arrhythmias other than AF

Patients with untreated hyperthyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 minute after shock delivered

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two shock treatments for cardiac defibrillation to see which is more effective and has fewer side effects. #MedicalResearch

Who is the study for?

This trial is for adults over 18 with Atrial Fibrillation (AF) who are stable and have a plan for electrical cardioversion. They must be properly anticoagulated or cleared of intracardiac thrombi by imaging. It's not for those on other trials, with unstable AF, other arrhythmias, untreated hyperthyroidism, pregnancy, or potential non-compliance.

What is being tested?

The study compares two defibrillators: Zoll using a single 200J RBW shock and Lifepak using a single 360J BTE shock in patients with AF. Participants will be randomly assigned to one of the devices to see which is more effective at restoring normal heart rhythm.

What are the potential side effects?

Possible side effects from the cardioversion may include skin irritation or burns where the defibrillator pads are placed, discomfort in the chest area due to shocks, short-term heart rhythm problems post-procedure, and very rarely more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have atrial fibrillation and am scheduled for a cardioversion procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a heart rhythm problem that is not atrial fibrillation.

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I have an overactive thyroid that hasn't been treated.

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My heart condition causes unstable blood pressure.

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I either lack proper blood thinning treatment or have confirmed no blood clots in my heart via scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 minute after shock delivered

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 minute after shock delivered

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 minute after shock delivered for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The number of participants in normal sinus rhythm (NSR) by ECG after the first DCCV shock

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Active Control

Group I: Lifepak defibrillator waveform used after unsuccessful second full output shock.Active Control1 Intervention

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.

Group II: Output synchronized to 200J using Zoll Rectilinear Biphasic Waveform (RBW) defibrillatorActive Control1 Intervention

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

Group III: Output synchronized to 360J Lifepak Biphasic Truncated Exponential Waveform (BTE) defibrillatorActive Control1 Intervention

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.

Group IV: Zoll defibrillator waveform used after unsuccessful second full output shock.Active Control1 Intervention

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.

0 / 6Eligibility criteria met