ArrhythmiaPhase 3NCT00000518
Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)
A Phase 3 study testing electrophysiology, electrocardiography, ambulatory and imipramine in people with Arrhythmia and Cardiovascular Diseases, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac
- What is being tested?
- electrophysiology, electrocardiography, ambulatory and imipramine
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1985to Dec 1992
- Phase
- Phase 3
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Men and women with documented ventricular tachycardia and those resuscitated from sudden death.
About this study
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.
Read the 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.
- Conditions
- Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Diseases, Tachycardia, Ventricular, Ventricular Arrhythmia
- Being tested
- electrophysiology, electrocardiography, ambulatory, imipramine, mexiletine, procainamide
- Medical subject headings
- Arrhythmias, Cardiac, Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Diseases, Tachycardia, Ventricular, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrophysiologyProcedure or surgery
electrocardiography, ambulatoryProcedure or surgery
imipramineDrug
mexiletineDrug
procainamideDrug
quinidineDrug
sotalolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJul 1985
- Study completionDec 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000518
- Sponsor's protocol ID
- 37
- Other IDs
- R01HL034071
- Status last verified
- Jan 2016
- First submitted
- 27 Oct 1999
- Last updated
- 21 Jan 2016
- Results posted
- No
Publications
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.
PubMed 2655967Freedman 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.
PubMed 1848871Bigger 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.
PubMed 1546643Determinants 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.
PubMed 8425281Mason 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.
PubMed 8332149Mason 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.
PubMed 8332150Lazzara 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.
PubMed 7513876Mason 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.
PubMed 8237831Omoigui 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.
PubMed 7850943Biblo 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.
PubMed 7759711Anderson 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.
PubMed 7541813Monograph on Lessons Learned from ESVEM.II -- Mason JW, Guest Editor.
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.
PubMed 8638023Saksena 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.
PubMed 8638024Saksena 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.
PubMed 8638025
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)
- ClinicalTrials.gov ID
- NCT00000518
- Acronym / sponsor ID
- 37
- Conditions
- Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Diseases, Tachycardia, Ventricular, Ventricular Arrhythmia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1985
- Study completion
- Dec 1992
- First posted
- 28 Oct 1999 (estimated)
- 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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| electrophysiology | Procedure or surgery | – |
| electrocardiography, ambulatory | Procedure or surgery | – |
| imipramine | Drug | – |
| mexiletine | Drug | – |
| procainamide | Drug | – |
| quinidine | Drug | – |
| sotalol | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Jan 2016.
- Background: PubMed 2655967The 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.
- Background: PubMed 1848871Freedman 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.
- Background: PubMed 1546643Bigger 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.
- Background: PubMed 8425281Determinants 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.
- Background: PubMed 8332149Mason 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.
- Background: PubMed 8332150Mason 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.
- Background: PubMed 7513876Lazzara 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.
- Background: PubMed 8237831Mason 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.
- Background: PubMed 7850943Omoigui 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.
- Background: PubMed 7759711Biblo 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.
- Background: PubMed 7541813Anderson 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.
- BackgroundMonograph on Lessons Learned from ESVEM.II -- Mason JW, Guest Editor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing electrophysiology, electrocardiography, ambulatory and imipramine in people with Arrhythmia and Cardiovascular Diseases, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000518, which also lists 43 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 21 Jan 2016.