Sudden Cardiac DeathEPS ARRESTNCT03079414
The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest
An observational study of Sudden Cardiac Death, run by Western University, Canada at 21 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Cardiac Death
- What is being tested?
- Invasive Electrophysiology Study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 1 May 2017to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Survivors of unexplained sudden cardiac death for whom an underlying etiology remains unclear following a standard diagnostic workup, including 12-lead surface ECG, coronary artery assessment, echocardiography, cardiac MRI with late gadolinium enhancement, procainamide challenge, and exercise treadmill testing.
Who may be able to join
- Unexplained cardiac arrest requiring cardioversion or defibrillation
- Willing and able to sign informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Queen's Medical Center
Honolulu, Hawaii, 96813
UCLA Medical Center
Los Angeles, California, 90095
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oregon Health & Science University
Portland, Oregon, 97239
Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah
Salt Lake City, Utah, 84132
UC San Diego Health System
San Diego, California, 92037
UCSF Medical Center
San Francisco, California, 94143-0124
Stanford University
Stanford, California, 94305
Canada9 sites
University of Calgary
Calgary, Alberta
QEII Health Sciences Centre
Halifax, Nova Scotia
Hamilton Health Sciences
Hamilton, Ontario
London Health Sciences Centre
London, Ontario, N6A 5A5
Montreal Heart Institute
Montreal, Quebec
Laval University
Québec, Quebec
Toronto General Hospital
Toronto, Ontario
British Columbia Children's Hospital
Vancouver, British Columbia
University of British Columbia
Vancouver, British Columbia
About this study
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.
Read the detailed description
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.
- Conditions
- Sudden Cardiac Death
- Being tested
- Invasive Electrophysiology Study
- Keywords
- Sudden Cardiac Death, Cardiac Arrhythmia, Electrophysiology Study, Genetics
- Medical subject headings
- Death, Sudden, Cardiac, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive Electrophysiology StudyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Unexplained Aborted Cardiac Arrest | Survivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup. Receives: Procedure: Invasive Electrophysiology Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmic culprit for aborted cardiac arrest
Identification of an arrhythmic culprit for aborted cardiac arrest using an invasive electrophysiology study.
Measured: Assessed immediately upon testing
Secondary outcomes (3)
Prevalence of bundle branch reentrant ventricular tachycardia
Prevalence of bundle branch reentrant ventricular tachycardia among survivors of unexplained cardiac arrest.
Measured: Assessed immediately upon testing
Prevalence of supraventricular tachycardia associated with hemodynamic collapse
Prevalence of inducible supraventricular tachycardia during invasive electrophysiology study among survivors of unexplained cardiac arrest.
Measured: Assessed immediately upon testing
Prevalence of a latent/cryptic accessory pathway
Prevalence of a latent/cryptic accessory pathway among survivors of unexplained cardiac arrest.
Measured: Assessed immediately upon testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start1 May 2017
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jason D Roberts, MD MAS, Principal investigator, Western UniversityAndrew D Krahn, MD, Study director, University of British ColumbiaMelvin M Scheinman, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079414
- Sponsor's protocol ID
- 108939
- Acronym
- EPS ARREST
- Status last verified
- Jun 2025
- First submitted
- 2 Mar 2017
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share IPD with other researchers.
Publications
Krahn AD, Healey JS, Chauhan V, Birnie DH, Simpson CS, Champagne J, Gardner M, Sanatani S, Exner DV, Klein GJ, Yee R, Skanes AC, Gula LJ, Gollob MH. Systematic assessment of patients with unexplained cardiac arrest: Cardiac Arrest Survivors With Preserved Ejection Fraction Registry (CASPER). Circulation. 2009 Jul 28;120(4):278-85. doi: 10.1161/CIRCULATIONAHA.109.853143. Epub 2009 Jul 13.
PubMed 19597050Wang YS, Scheinman MM, Chien WW, Cohen TJ, Lesh MD, Griffin JC. Patients with supraventricular tachycardia presenting with aborted sudden death: incidence, mechanism and long-term follow-up. J Am Coll Cardiol. 1991 Dec;18(7):1711-9. doi: 10.1016/0735-1097(91)90508-7.
PubMed 1960318Roberts JD, Gollob MH, Young C, Connors SP, Gray C, Wilton SB, Green MS, Zhu DW, Hodgkinson KA, Poon A, Li Q, Orr N, Tang AS, Klein GJ, Wojciak J, Campagna J, Olgin JE, Badhwar N, Vedantham V, Marcus GM, Kwok PY, Deo RC, Scheinman MM. Bundle Branch Re-Entrant Ventricular Tachycardia: Novel Genetic Mechanisms in a Life-Threatening Arrhythmia. JACC Clin Electrophysiol. 2017 Mar;3(3):276-288. doi: 10.1016/j.jacep.2016.09.019. Epub 2016 Dec 21.
PubMed 29759522
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03079414
- Acronym / sponsor ID
- EPS ARREST / 108939
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden Cardiac Death, Cardiac Arrhythmia, Electrophysiology Study, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unexplained Aborted Cardiac Arrest | – | Procedure: Invasive Electrophysiology StudySurvivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Survivors of unexplained sudden cardiac death for whom an underlying etiology remains unclear following a standard diagnostic workup, including 12-lead surface ECG, coronary artery assessment, echocardiography, cardiac MRI with late gadolinium enhancement, procainamide challenge, and exercise treadmill testing.
Key inclusion criteria (2 listed)
- Unexplained cardiac arrest requiring cardioversion or defibrillation
- Willing and able to sign informed consent
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive Electrophysiology StudyInvasive 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. | Procedure or surgery | Unexplained Aborted Cardiac Arrest |
Primary outcome
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.
3 secondary outcomes
Prevalence of bundle branch reentrant ventricular tachycardia
Time frame: Assessed immediately upon testing
Prevalence of supraventricular tachycardia associated with hemodynamic collapse
Time frame: Assessed immediately upon testing
Prevalence of a latent/cryptic accessory pathway
Time frame: Assessed immediately upon testing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 19597050Krahn AD, Healey JS, Chauhan V, Birnie DH, Simpson CS, Champagne J, Gardner M, Sanatani S, Exner DV, Klein GJ, Yee R, Skanes AC, Gula LJ, Gollob MH. Systematic assessment of patients with unexplained cardiac arrest: Cardiac Arrest Survivors With Preserved Ejection Fraction Registry (CASPER). Circulation. 2009 Jul 28;120(4):278-85. doi: 10.1161/CIRCULATIONAHA.109.853143. Epub 2009 Jul 13.
- Background: PubMed 1960318Wang YS, Scheinman MM, Chien WW, Cohen TJ, Lesh MD, Griffin JC. Patients with supraventricular tachycardia presenting with aborted sudden death: incidence, mechanism and long-term follow-up. J Am Coll Cardiol. 1991 Dec;18(7):1711-9. doi: 10.1016/0735-1097(91)90508-7.
- Background: PubMed 29759522Roberts JD, Gollob MH, Young C, Connors SP, Gray C, Wilton SB, Green MS, Zhu DW, Hodgkinson KA, Poon A, Li Q, Orr N, Tang AS, Klein GJ, Wojciak J, Campagna J, Olgin JE, Badhwar N, Vedantham V, Marcus GM, Kwok PY, Deo RC, Scheinman MM. Bundle Branch Re-Entrant Ventricular Tachycardia: Novel Genetic Mechanisms in a Life-Threatening Arrhythmia. JACC Clin Electrophysiol. 2017 Mar;3(3):276-288. doi: 10.1016/j.jacep.2016.09.019. Epub 2016 Dec 21.
- Individual participant dataSharing planned: No. There is no current plan to share IPD with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason D Roberts, MD MAS principal investigator
Western University
Andrew D Krahn, MD study director
University of British Columbia
Melvin M Scheinman, MD study director
University of California, San Francisco
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by Western University, Canada at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arrhythmic culprit for aborted cardiac arrest (time frame: Assessed immediately upon testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079414, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.