The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest (EPS ARREST)
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|ClinicalTrials.gov Identifier: NCT03079414|
Recruitment Status : Recruiting
First Posted : March 14, 2017
Last Update Posted : September 23, 2019
|Condition or disease||Intervention/treatment|
|Sudden Cardiac Death||Procedure: Invasive Electrophysiology 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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest|
|Actual Study Start Date :||May 1, 2017|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||May 31, 2020|
Unexplained Aborted Cardiac Arrest
Survivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup.
Procedure: Invasive Electrophysiology Study
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.
- 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.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079414
|Contact: Jason D Roberts, MD MAS||(519) 663-3746 ext firstname.lastname@example.org|
|Principal Investigator:||Jason D Roberts, MD MAS||Western University|
|Study Director:||Andrew D Krahn, MD||University of British Columbia|
|Study Director:||Melvin M Scheinman, MD||University of California, San Francisco|