Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

NCT00000518 | Completed Phase 3

• 2 other identifiers: 37R01HL034071
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better method for selecting effective long-term antiarrhythmic drug therapy in patients with sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden death.

Conditions

Arrhythmia; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Arrhythmia; Ventricular Fibrillation

Interventions

electrophysiology PROCEDURE

electrocardiography, ambulatory PROCEDURE

imipramine DRUG

mexiletine DRUG

procainamide DRUG

quinidine DRUG

sotalol DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Men and women with documented ventricular tachycardia and those resuscitated from sudden death.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (43)

• The ESVEM trial. Electrophysiologic Study Versus Electrocardiographic Monitoring for selection of antiarrhythmic therapy of ventricular tachyarrhythmias. The ESVEM Investigators. Circulation. 1989 Jun;79(6):1354-60. doi: 10.1161/01.cir.79.6.1354.

  PMID: 2655967 BACKGROUND

• Freedman RA, Steinberg JS. Selective prolongation of QRS late potentials by sodium channel blocking antiarrhythmic drugs: relation to slowing of ventricular tachycardia. Electrophysiologic Study Versus Electrocardiographic Monitoring Trial (ESVEM) Investigators. J Am Coll Cardiol. 1991 Apr;17(5):1017-25. doi: 10.1016/0735-1097(91)90824-s.

  PMID: 1848871 BACKGROUND

• Bigger JT Jr, Fleiss JL, Rolnitzky LM, Steinman RC. Stability over time of heart period variability in patients with previous myocardial infarction and ventricular arrhythmias. The CAPS and ESVEM investigators. Am J Cardiol. 1992 Mar 15;69(8):718-23. doi: 10.1016/0002-9149(92)90493-i.

  PMID: 1546643 BACKGROUND

• Determinants of predicted efficacy of antiarrhythmic drugs in the electrophysiologic study versus electrocardiographic monitoring trial. The ESVEM Investigators. Circulation. 1993 Feb;87(2):323-9. doi: 10.1161/01.cir.87.2.323.

  PMID: 8425281 BACKGROUND

• Mason JW. A comparison of electrophysiologic testing with Holter monitoring to predict antiarrhythmic-drug efficacy for ventricular tachyarrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring Investigators. N Engl J Med. 1993 Aug 12;329(7):445-51. doi: 10.1056/NEJM199308123290701.

  PMID: 8332149 BACKGROUND

• Mason JW. A comparison of seven antiarrhythmic drugs in patients with ventricular tachyarrhythmias. Electrophysiologic Study versus Electrocardiographic Monitoring Investigators. N Engl J Med. 1993 Aug 12;329(7):452-8. doi: 10.1056/NEJM199308123290702.

  PMID: 8332150 BACKGROUND

• Lazzara R. Results of Holter ECG guided therapy for ventricular arrhythmias: the ESVEM trial. Pacing Clin Electrophysiol. 1994 Mar;17(3 Pt 2):473-7. doi: 10.1111/j.1540-8159.1994.tb01415.x.

  PMID: 7513876 BACKGROUND

• Mason JW. Implications of the ESVEM trial for use of antiarrhythmic drugs that prolong cardiac repolarization. Am J Cardiol. 1993 Nov 26;72(16):59F-61F. doi: 10.1016/0002-9149(93)90964-e.

  PMID: 8237831 BACKGROUND

• Omoigui NA, Marcus FI, Mason JW, Hahn EA, Hartz VL, Hlatky MA. Cost of initial therapy in the Electrophysiological Study Versus ECG Monitoring trial (ESVEM). Circulation. 1995 Feb 15;91(4):1070-6. doi: 10.1161/01.cir.91.4.1070.

  PMID: 7850943 BACKGROUND

• Biblo LA, Carlson MD, Waldo AL. Insights into the Electrophysiology Study Versus Electrocardiographic Monitoring Trial: its programmed stimulation protocol may introduce bias when assessing long-term antiarrhythmic drug therapy. J Am Coll Cardiol. 1995 Jun;25(7):1601-4. doi: 10.1016/0735-1097(95)00087-k.

  PMID: 7759711 BACKGROUND

• Anderson KP, Walker R, Dustman T, Fuller M, Mori M. Spontaneous sustained ventricular tachycardia in the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Trial. J Am Coll Cardiol. 1995 Aug;26(2):489-96. doi: 10.1016/0735-1097(95)80027-e.

  PMID: 7541813 BACKGROUND

• Monograph on Lessons Learned from ESVEM.II -- Mason JW, Guest Editor.

  BACKGROUND

• Steinbeck G, Greene HL. Management of patients with life-threatening sustained ventricular tachyarrhythmias--the role of guided antiarrhythmic drug therapy. Prog Cardiovasc Dis. 1996 May-Jun;38(6):419-28. doi: 10.1016/s0033-0620(96)80006-5.

  PMID: 8638023 BACKGROUND

• Saksena S, Breithardt G, Dorian P, Greene HL, Madan N, Block M. Nonpharmacological therapy for malignant ventricular arrhythmias: implantable defibrillator trials. Prog Cardiovasc Dis. 1996 May-Jun;38(6):429-44. doi: 10.1016/s0033-0620(96)80007-7.

  PMID: 8638024 BACKGROUND

• Saksena S, Madan N, Lewis C. Implanted cardioverter-defibrillators are preferable to drugs as primary therapy in sustained ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):445-54. doi: 10.1016/s0033-0620(96)80008-9.

  PMID: 8638025 BACKGROUND

• Garan H. A perspective on the ESVEM trial current knowledge: sotalol should not be the first-line agent in the management of ventricular arrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):455-6. doi: 10.1016/s0033-0620(96)80009-0.

  PMID: 8638026 BACKGROUND

• Garan H. A perspective on the ESVEM trial and current knowledge: catheter ablation for ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 May-Jun;38(6):457-62. doi: 10.1016/s0033-0620(96)80010-7.

  PMID: 8638027 BACKGROUND

• Anderson KP, Bigger JT Jr, Freedman RA. Electrocardiographic predictors in the ESVEM trial: unsustained ventricular tachycardia, heart period variability, and the signal-averaged electrocardiogram. Prog Cardiovasc Dis. 1996 May-Jun;38(6):463-88. doi: 10.1016/s0033-0620(96)80011-9.

  PMID: 8638028 BACKGROUND

• Anderson KP, Hartz VL, Hahn EA, Moon TE. Design and analysis of the ESVEM Trial. Prog Cardiovasc Dis. 1996 May-Jun;38(6):489-502. doi: 10.1016/s0033-0620(96)80012-0.

  PMID: 8638029 BACKGROUND

• Winters SL, Curwin JH. Sotalol and the management of ventricular arrhythmias: implications of ESVEM. Pacing Clin Electrophysiol. 1995 Mar;18(3 Pt 1):377-8. doi: 10.1111/j.1540-8159.1995.tb02534.x. No abstract available.

  PMID: 7770355 BACKGROUND

• Reiter MJ, Mann DE, Reiffel JE, Hahn E, Hartz V. Significance and incidence of concordance of drug efficacy predictions by Holter monitoring and electrophysiological study in the ESVEM Trial. Electrophysiologic Study Versus Electrocardiographic Monitoring. Circulation. 1995 Apr 1;91(7):1988-95. doi: 10.1161/01.cir.91.7.1988.

  PMID: 7895357 BACKGROUND

• Gettes LS. ESVEM and the hazards of clinical trials. Circulation. 1995 Apr 1;91(7):1908-9. doi: 10.1161/01.cir.91.7.1908. No abstract available.

  PMID: 7895345 BACKGROUND

• Campbell RW. Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: impact on algorithm for drug selection. Coron Artery Dis. 1994 Aug;5(8):682-5. doi: 10.1097/00019501-199408000-00006. No abstract available.

  PMID: 8000621 BACKGROUND

• d'Avila A, Fenelon G, Nellens P, Brugada P. Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: electrocardiographic monitoring advocates' view. Coron Artery Dis. 1994 Aug;5(8):677-81. doi: 10.1097/00019501-199408000-00005. No abstract available.

  PMID: 8000620 BACKGROUND

• Mitchell LB, Wyse DG. Interpretation of the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) study: programmed ventricular stimulation advocates view. Coron Artery Dis. 1994 Aug;5(8):671-6. doi: 10.1097/00019501-199408000-00004. No abstract available.

  PMID: 8000619 BACKGROUND

• Klein RC. Comparative efficacy of sotalol and class I antiarrhythmic agents in patients with ventricular tachycardia or fibrillation: results of the Electrophysiology Study Versus Electrocardiographic Monitoring (ESVEM) Trial. Eur Heart J. 1993 Nov;14 Suppl H:78-84. doi: 10.1093/eurheartj/14.suppl_h.78.

  PMID: 8293756 BACKGROUND

• Monograph on Lessons Learned from ESVEM I. Mason JW, Guest Editor. Publications in the monograph are the results of a meeting in August 1995 of the ESVEM investigators and a number of non-ESVEM investigators prominent in the field of electrophysiology. The purpose of the meeting was to discuss the impact of ESVEM and developments in the field.

  BACKGROUND

• Mason JW, Marcus FI, Bigger JT, Lazzara R, Reiffel JA, Reiter MJ, Mann D. A summary and assessment of the findings and conclusions of the ESVEM trial. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):347-58. doi: 10.1016/s0033-0620(96)80028-4.

  PMID: 8604439 BACKGROUND

• Reiffel JA, Reiter MJ, Freedman RA, Mann D, Huang SK, Hahn E, Hartz V, Mason J; ESVEM Investigators. Influence of Holter monitor and electrophysiologic study methods and efficacy criteria on the outcome of patients with ventricular tachycardia and ventricular fibrillation in the ESVEM trial. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):359-70. doi: 10.1016/s0033-0620(96)80029-6.

  PMID: 8604440 BACKGROUND

• Hlatky MA. Cost and efficacy analysis in the ESVEM trial: implications for diagnosis and therapy for ventricular tachyarrhythmias. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):371-6. doi: 10.1016/s0033-0620(96)80030-2.

  PMID: 8604441 BACKGROUND

• Mitchell LB, Duff HJ, Gillis AM, Ramadan D, Wyse DG. A randomized clinical trial of the noninvasive and invasive approaches to drug therapy for ventricular tachycardia: long-term follow-up of the Calgary trial. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):377-84. doi: 10.1016/s0033-0620(96)80031-4.

  PMID: 8604442 BACKGROUND

• Takami Y, Ohtsuka G, Mueller J, Ebner M, Tayama E, Ohashi Y, Taylor D, Fernandes J, Schima H, Schmallegger H, Wolner E, Nose Y. Current progress in the development of a totally implantable Gyro centrifugal artificial heart. ASAIO J. 1998 May-Jun;44(3):207-11. doi: 10.1097/00002480-199805000-00016.

  PMID: 9617953 BACKGROUND

• Anderson J. Implantable defibrillators are preferable to pharmacologic therapy for patients with ventricular tachyarrhythmias: an antagonist's viewpoint. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):393-400. doi: 10.1016/s0033-0620(96)80033-8.

  PMID: 8604444 BACKGROUND

• Cannom DS, Ruggio J. Specialty care at the crossroads: electrophysiology practice in the managed-care era. Prog Cardiovasc Dis. 1996 Mar-Apr;38(5):401-6. doi: 10.1016/s0033-0620(96)80034-x.

  PMID: 8604445 BACKGROUND

• Reiter MJ, Karagounis LA, Mann DE, Reiffel JA, Hahn E, Hartz V. Reproducibility of drug efficacy predictions by Holter monitoring in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. ESVEM Investigators. Am J Cardiol. 1997 Feb 1;79(3):315-22. doi: 10.1016/s0002-9149(96)00754-0.

  PMID: 9036751 BACKGROUND

• Prystowsky EN. Electrophysiologic Study versus Electrocardiographic Monitoring (ESVEM): a critical appraisal. Control Clin Trials. 1996 Jun;17(3 Suppl):28S-36S. doi: 10.1016/s0197-2456(96)00042-6.

  PMID: 8877265 BACKGROUND

• Reiffel JA. Implications of the Electrophysiologic Study versus Electrocardiographic Monitoring trial for controlling ventricular tachycardia and fibrillation. Am J Cardiol. 1996 Aug 29;78(4A):34-40. doi: 10.1016/s0002-9149(96)00451-1.

  PMID: 8780327 BACKGROUND

• Karagounis LA, Stein KM, Bair T, Albright D, Anderson JL. Fractal dimension predicts arrhythmia recurrence in patients being treated for life-threatening ventricular arrhythmias. ESVEM Investigators. J Electrocardiol. 1995;28 Suppl:71-3. doi: 10.1016/s0022-0736(95)80019-0. No abstract available.

  PMID: 8656133 BACKGROUND

• Reiffel JA, Hahn E, Hartz V, Reiter MJ. Sotalol for ventricular tachyarrhythmias: beta-blocking and class III contributions, and relative efficacy versus class I drugs after prior drug failure. ESVEM Investigators. Electrophysiologic Study Versus Electrocardiographic Monitoring. Am J Cardiol. 1997 Apr 15;79(8):1048-53. doi: 10.1016/s0002-9149(97)00045-3.

  PMID: 9114762 BACKGROUND

• Caruso AC, Marcus FI, Hahn EA, Hartz VL, Mason JW. Predictors of arrhythmic death and cardiac arrest in the ESVEM trial. Electrophysiologic Study Versus Electromagnetic Monitoring. Circulation. 1997 Sep 16;96(6):1888-92. doi: 10.1161/01.cir.96.6.1888.

  PMID: 9323077 BACKGROUND

• Mann DE, Hartz V, Hahn EA, Reiter MJ. Effect of reproducibility of baseline arrhythmia induction on drug efficacy predictions and outcome in the Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) trial. Am J Cardiol. 1997 Dec 1;80(11):1448-52. doi: 10.1016/s0002-9149(97)00729-7.

  PMID: 9399720 BACKGROUND

• Olshansky B, Hartz V, Hahn E, Mason J, Weaver MD; ESVEM Investigators. Location of death (in-hospital or out-of-hospital) and type of death (arrhythmic, nonarrhythmic, noncardiac) after inducible sustained ventricular tachyarrhythmias after syncope, sustained ventricular tachycardia, or nonfatal cardiac arrest (the ESVEM trial). Am J Cardiol. 2000 Oct 15;86(8):846-51. doi: 10.1016/s0002-9149(00)01104-8.

  PMID: 11024399 BACKGROUND

• Olshansky B, Hahn EA, Hartz VL, Prater SP, Mason JW. Clinical significance of syncope in the electrophysiologic study versus electrocardiographic monitoring (ESVEM) trial. The ESVEM Investigators. Am Heart J. 1999 May;137(5):878-86. doi: 10.1016/s0002-8703(99)70412-6.

  PMID: 10220637 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Cardiovascular Diseases; Death, Sudden, Cardiac; Heart Diseases; Tachycardia, Ventricular; Ventricular Fibrillation

Interventions

Ambulatory Care Facilities; Imipramine; Mexiletine; Procainamide; Quinidine; Sotalol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Arrest; Death, Sudden; Death; Tachycardia; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Organic Chemicals; Phenyl Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Ethanolamines; Amino Alcohols; Alcohols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: July 1, 1985
• Study Completion: December 1, 1992
• Last Updated: January 21, 2016

Record last verified: 2016-01