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NCT Number: NCT03079414

The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

Sudden cardiac death (SCD) remains a major cause of mortality within developed nations despite aggressive efforts to reduce its societal burden. Despite extensive clinical and genetic investigations, a subgroup of cardiac arrests remain unexplained, highlighting the potential contribution of additional cardiac conditions that may not be identified with contemporary diagnostic algorithms. The EPS ARREST study aims to evaluate the role of invasive electrophysiology study within this patient population.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

The majority of cases of SCD in older individuals occur secondary to coronary and structural heart disease, while genetic channelopathies and cardiomyopathies are prominent contributors in young adults. Among individuals that suffer aborted cardiac arrests in the absence of overt coronary and structural heart disease, diagnostic algorithms that screen for cardiac channelopathies and more subtle forms of structural heart disease have been established. Despite the extensive investigations currently utilized, a significant proportion of aborted cardiac arrests remain unexplained.

Although invasive electrophysiology studies are a cornerstone for diagnosis and management of arrhythmia disorders, they are not invariably included in the workup of cases of unexplained aborted cardiac arrest. This is largely driven by initial studies suggesting that the diagnostic yield in this context is low, however these investigations often used invasive electrophysiology studies indiscriminately in all cases of aborted cardiac arrest. Since these earlier studies, our insight and approach to SCD has evolved and it has become clear that the majority of patients do not require an invasive electrophysiology study for diagnosis. However an invasive electrophysiology study may still have an important role among these individuals when the initial workup is negative. Notably, arrhythmias that require invasive electrophysiology for diagnosis, including bundle branch reentrant ventricular tachycardia and supraventricular tachycardias associated with hemodynamic collapse, have been identified as arrhythmic culprits in this patient population.

The goal of the EPS ARREST study is to evaluate the diagnostic yield of a standardized invasive electrophysiology study among survivors of SCD when initial investigations fail to identify an underlying etiology.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unexplained cardiac arrest requiring cardioversion or defibrillation
  • Willing and able to sign informed consent

Exclusion criteria

  • Coronary artery disease (stenosis > 50%) and clinical findings consistent with an ischemic arrest
  • Reduced left ventricular function (left ventricular ejection fraction < 50%) on echocardiogram or cardiac MRI.
  • Persistent resting QTc > 460 msec for males and 480 msec for females
  • Resting QTc < 350 msec
  • Type I Brugada ECG with >/= 2 mm ST elevation in V1 and/or V2 (Spontaneous or Drug-Induced)
  • Polymorphic or bidirectional ventricular tachycardia observed with exertion on exercise treadmill testing
  • Clinical, electrocardiographic, and/or imaging findings consistent with a diagnosis of arrhythmogenic right ventricular cardiomyopathy
  • Myocarditis
  • Reversible cause of cardiac arrest such as marked hypokalemia (<2.8 mmol/l) or drug overdose sufficient in severity without other cause to explain the cardiac arrest.
  • Arrhythmic mitral valve prolapse syndrome
  • Documented ventricular fibrillation initiated by a short-coupled premature ventricular contraction

Treatment and study plan

Invasive Electrophysiology Study

Procedure

Invasive electrophysiology studies will be performed using four catheters placed in the right ventricular apex, the coronary sinus, the His bundle region, and the high right atrium. Standard induction protocols for supraventricular and ventricular arrhythmias will be utilized in the absence and presence of isoproterenol. Long-short ventricular extra-stimuli will also be delivered to screen for bundle branch reentrant ventricular tachycardia. The study is considered observational as the participating sites perform electrophysiology studies in this patient population as part of standard clinical care.

Primary outcomes

  1. Arrhythmic culprit for aborted cardiac arrest

    Time frame: Assessed immediately upon testing

    Identification of an arrhythmic culprit for aborted cardiac arrest using an invasive electrophysiology study.

Secondary outcomes

  1. Prevalence of bundle branch reentrant ventricular tachycardia

    Time frame: Assessed immediately upon testing

    Prevalence of bundle branch reentrant ventricular tachycardia among survivors of unexplained cardiac arrest.

  2. Prevalence of supraventricular tachycardia associated with hemodynamic collapse

    Time frame: Assessed immediately upon testing

    Prevalence of inducible supraventricular tachycardia during invasive electrophysiology study among survivors of unexplained cardiac arrest.

  3. Prevalence of a latent/cryptic accessory pathway

    Time frame: Assessed immediately upon testing.

    Prevalence of a latent/cryptic accessory pathway among survivors of unexplained cardiac arrest.

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: EPS ARREST

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Mar 14, 2017
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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