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Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000518
First Posted: October 28, 1999
Last Update Posted: January 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Utah
  Purpose
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.

Condition Intervention Phase
Arrhythmia Cardiovascular Diseases Death, Sudden, Cardiac Heart Diseases Tachycardia, Ventricular Ventricular Arrhythmia Ventricular Fibrillation Procedure: electrophysiology Procedure: electrocardiography, ambulatory Drug: imipramine Drug: mexiletine Drug: procainamide Drug: quinidine Drug: sotalol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Utah:

Study Start Date: July 1985
Estimated Study Completion Date: December 1992
Detailed Description:

BACKGROUND:

There had been no prospective, randomized studies that compared the accuracy of EPS versus HM in guiding long-term drug therapy for ventricular tachycardia or ventricular fibrillation. Success had been reported using both techniques. Using a rigorous ECG monitoring protocol in patients, a less than five percent per year incidence of sudden death had been reported. Several investigators reported that the results of electropharmacologic testing were predictive of clinical response. One of the largest studies, by Mason and Winkle, reported that, in 51 patients with recurrent ventricular tachycardia who were treated with drugs predicted to be effective based on the results of electropharmacologic testing, ventricular tachycardia did not recur in 68 percent at 18 months of follow-up. In contrast, ventricular tachycardia did not recur in only 11 percent of patients treated with drugs predicted to be ineffective.

Two prior studies had compared, in a non-randomized fashion, the predictive accuracy of EPS and HM in treating patients with ventricular tachycardia/ ventricular fibrillation. A retrospective analysis of 44 patients with ventricular tachycardia/ventricular fibrillation who underwent both HM and EPS was performed in which the elimination of ventricular tachycardia on the HM and the suppression of ventricular tachycardia induced during programmed stimulation was the therapeutic goal. The positive and negative predictive value of EPS was found to be 88 percent and 94 percent, respectively. The corresponding values for ECG monitoring were found to be 70 percent and 50 percent, respectively. It was concluded that EPS provided a higher degree of accuracy than HM in predicting the long-term clinical response to drug therapy, over a mean follow-up of 18 months. However, in this study the criterion for judging efficacy by HM was a liberal one and involved only the elimination of ventricular tachycardia.

A second study examined the results of HM in 19 patients with ventricular tachycardia who were treated based on EPS. Among eight patients, in whom inducible ventricular tachycardia was suppressed during electrophysiologic testing, six had no change or worsening of premature ventricular contractions on the HM. These patients had a benign follow-up despite the continued presence of frequent or complex ventricular ectopy. It was concluded that EPS was superior to HM in predicting successful drug therapy.

Existing data suggested that both electrophysiologic testing and Holter monitoring might be effective techniques for determining effective drug therapy for ventricular tachycardia/ventricular fibrillation. However, there was not enough data available to assess which technique was more effective. A prospective, randomized comparison of the two techniques would be a very significant contribution which could potentially have a major impact on the medical community.

DESIGN NARRATIVE:

Randomized, fixed sample, multicenter trial conducted at 14 institutions. Patients meeting clinical criteria underwent Holter monitoring. Those having an average of 30 premature ventricular contractions per hour underwent EPS. Those having inducible ventricular tachycardia were randomized into an EPS arm or to a Holter exercise treadmill arm of drug testing. Each patient received, in random sequences, up to six antiarrhythmic drugs. When an effective drug was found, patients underwent a predischarge HM and exercise test. Follow-up continued for one year after the last subject had been randomized. The primary endpoint in the trial was time to arrhythmia recurrence during therapy with a drug predicted to be effective by either EPS or HM.

  Eligibility

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women with documented ventricular tachycardia and those resuscitated from sudden death.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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

ClinicalTrials.gov Identifier: NCT00000518     History of Changes
Other Study ID Numbers: 37
R01HL034071 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: January 21, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Tachycardia
Ventricular Fibrillation
Death, Sudden
Death, Sudden, Cardiac
Tachycardia, Ventricular
Arrhythmias, Cardiac
Pathologic Processes
Death
Heart Arrest
Imipramine
Quinidine
Sotalol
Mexiletine
Procainamide
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents
Antimalarials