The Role of Electrophysiology Testing in Survivors of Unexplained Cardiac Arrest

NCT03079414 | Completed

• 1 other identifier: 108939
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 21

Brief 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 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.

Conditions

Sudden Cardiac Death

Keywords

Sudden Cardiac Death; Cardiac Arrhythmia; Electrophysiology Study; Genetics

Outcome Measures

Primary Outcomes (1)

• Arrhythmic culprit for aborted cardiac arrest

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

  Assessed immediately upon testing

Secondary Outcomes (3)

• Prevalence of bundle branch reentrant ventricular tachycardia

  Assessed immediately upon testing

• Prevalence of supraventricular tachycardia associated with hemodynamic collapse

  Assessed immediately upon testing

• Prevalence of a latent/cryptic accessory pathway

  Assessed immediately upon testing.

Study Arms (1)

Unexplained Aborted Cardiac Arrest

Survivors of sudden cardiac death with no identifiable etiology following initial diagnostic workup.

Procedure: Invasive Electrophysiology Study

Interventions

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.

Unexplained Aborted Cardiac Arrest

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (21)

UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UC San Diego Health System

San Diego, California, 92037, United States

Location

UCSF Medical Center

San Francisco, California, 94143-0124, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

University of Calgary

Calgary, Alberta, Canada

Location

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Laval University

Québec, Quebec, Canada

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Related Publications (3)

• 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.

  PMID: 19597050 BACKGROUND

• Wang 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.

  PMID: 1960318 BACKGROUND

• Roberts 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.

  PMID: 29759522 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA will attempted to be collected for all patients.

MeSH Terms

Conditions

Death, Sudden, Cardiac; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason D Roberts, MD MAS

  Western University

  PRINCIPAL INVESTIGATOR

• Andrew D Krahn, MD

  University of British Columbia

  STUDY DIRECTOR

• Melvin M Scheinman, MD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 14, 2017
• Study Start: May 1, 2017
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9); IL (1); US (11)