Antiarrhythmics Versus Implantable Defibrillators (AVID)

This study has been completed.

First Received: October 27, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000531

Purpose

To evaluate if use of an implantable cardiac defibrillator (ICD) results in reduction in total mortality, when compared with conventional pharmacological therapy, in patients resuscitated from sudden cardiac death who are otherwise at very high risk of mortality from arrhythmic causes.

Condition	Intervention	Phase
Arrhythmia Cardiovascular Diseases Death, Sudden, Cardiac Heart Diseases Tachycardia, Ventricular Ventricular Fibrillation	Device: defibrillators, implantable Drug: amiodarone amiodarone Drug: sotalol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome catecholaminergic polymorphic ventricular tachycardia short QT syndrome

MedlinePlus related topics: Arrhythmia Cardiac Arrest Heart Diseases Pacemakers and Implantable Defibrillators

Drug Information available for: Amiodarone hydrochloride Amidox Sotalol hydrochloride Amiodarone Sotalol

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:	September 1992
Estimated Study Completion Date:	August 2002

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men & women with VF, VT with syncope, or VT without syncope, but with ejection fraction less than or equal to .40 & systolic blood pressure less than 80 mm Hg, chest pain , or near syncope.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000531

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Alfred Hallstrom

University of Washington

More Information

Publications:

[No authors listed] Antiarrhythmics Versus Implantable Defibrillators (AVID)--rationale, design, and methods. Am J Cardiol. 1995 Mar 1;75(7):470-5.

Mower MM. AVID necessity. Pacing Clin Electrophysiol. 1994 Feb;17(2):258-60; discussion 262-6. No abstract available.

Fogoros RN. An AVID dissent. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 1):1707-11.

Connolly SJ. "An AVID dissent": commentary. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 1):1712-3.

Singer I. AVID necessity. Pacing Clin Electrophysiol. 1994 Feb;17(2):260-2; discussion 262-6. No abstract available.

Brooks MM, Hallstrom A, Peckova M. A simulation study used to design the sequential monitoring plan for a clinical trial. Stat Med. 1995 Oct 30;14(20):2227-37.

Curtis AB, Hallstrom AP, Klein RC, Nath S, Pinski SL, Epstein AE, Wyse G, Cannom DS, Renfroe E. Influence of patient characteristics in the selection of patients for defibrillator implantation (the AVID Registry). Antiarrhythmics Versus Implantable Defibrillators. Am J Cardiol. 1997 May 1;79(9):1185-9.

Josephson ME, Nisam S. The AVID trial: evidence based or randomized control trials--is the AVID study too late? Antiarrhythmics Versus Implantable Defibrillators. Am J Cardiol. 1997 Jul 15;80(2):194-7.

[No authors listed] Are implantable cardioverter-defibrillators or drugs more effective in prolonging life? The Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial Executive Committee. Am J Cardiol. 1997 Mar 1;79(5):661-3. No abstract available.

Domanski MJ, Saksena S, Wyse G, Hallstrom A, Schron EB, Nanda A, Nanda A, Kutalek S. Clinical and socioeconomic profile of patients with malignant ventricular arrhythmias in 1993 to 1995. AVID investigators. Antiarrhythmics Versus Implantable Defibrillator. Am J Cardiol. 1997 Aug 1;80(3):299-301.

Kim SG, Hallstrom A, Love JC, Rosenberg Y, Powell J, Roth J, Brodsky M, Moore R, Wilkoff B. Comparison of clinical characteristics and frequency of implantable defibrillator use between randomized patients in the Antiarrhythmics Vs Implantable Defibrillators (AVID) trial and nonrandomized registry patients. Am J Cardiol. 1997 Aug 15;80(4):454-7.

[No authors listed] A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med. 1997 Nov 27;337(22):1576-83.

Fogoros RN. Why the antiarrhythmics versus implantable defibrillator (AVID) trial sets the wrong precedent. Am J Cardiol. 1997 Sep 15;80(6):762-5. No abstract available.

Jenkins LS, Steinberg JS, Kutalek SP, et al: Quality of life in patients enrolled in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. Circulation 1997;96:I-439

Larsen GC, McAnulty JH, Hallstrom A, et al: Hospitalization charges in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial: the AVID economic analysis study. Circulation 1997;96:I-77

Myerburg RJ, Castellanos A. Clinical trials of implantable defibrillators. N Engl J Med. 1997 Nov 27;337(22):1621-3. No abstract available.

Singer I, Nisam S. There should never be another antiarrhythmics versus implantable defibrillator (AVID) trial. Am J Cardiol. 1997 Sep 15;80(6):766-8. No abstract available.

Kimm SG, Love J, Rosenberg Y, Powell J, AVID Investigators: Therapy in the AVID (Antiarrhythmics Versus Implantable Defibrillators) Trial is not signifcantly different from current clinical practice. Circulation 1995;92:I782

Brooks MM, Jenkins LS, Schron EB, Steinberg JS, Cross JA, Paeth DS. Quality of life at baseline: is assessment after randomization valid? The AVID Investigators. The Antiarrhythmics Versus Implantable Defibrillators. Med Care. 1998 Oct;36(10):1515-9.

Anderson JL, Hallstrom AP, Epstein AE, Pinski SL, Rosenberg Y, Nora MO, Chilson D, Cannom DS, Moore R. Design and results of the antiarrhythmics vs implantable defibrillators (AVID) registry. The AVID Investigators. Circulation. 1999 Apr 6;99(13):1692-9.

Domanski MJ, Sakseena S, Epstein AE, Hallstrom AP, Brodsky MA, Kim S, Lancaster S, Schron E. Relative effectiveness of the implantable cardioverter-defibrillator and antiarrhythmic drugs in patients with varying degrees of left ventricular dysfunction who have survived malignant ventricular arrhythmias. AVID Investigators. Antiarrhythmics Versus Implantable Defibrillators. J Am Coll Cardiol. 1999 Oct;34(4):1090-5.

Epstein AE, Powell J, Yao Q, Ocampo C, Lancaster S, Rosenberg Y, Cannom DS, Herre JM, Greene HL. In-hospital versus out-of-hospital presentation of life-threatening ventricular arrhythmias predicts survival: results from the AVID Registry. Antiarrhythmics Versus Implantable Defibrillators. J Am Coll Cardiol. 1999 Oct;34(4):1111-6.

[No authors listed] Causes of death in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J Am Coll Cardiol. 1999 Nov 1;34(5):1552-9.

Exner DV, Reiffel JA, Epstein AE, Ledingham R, Reiter MJ, Yao Q, Duff HJ, Follmann D, Schron E, Greene HL, Carlson MD, Brodsky MA, Akiyama T, Baessler C, Anderson JL. Beta-blocker use and survival in patients with ventricular fibrillation or symptomatic ventricular tachycardia: the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. J Am Coll Cardiol. 1999 Aug;34(2):325-33.

Pinski SL, Yao Q, Epstein AE, Lancaster S, Greene HL, Pacifico A, Cook JR, Jadonath R, Marinchak RA. Determinants of outcome in patients with sustained ventricular tachyarrhythmias: the antiarrhythmics versus implantable defibrillators (AVID) study registry. Am Heart J. 2000 May;139(5):804-13.

Raitt MH, Renfroe EG, Epstein AE, McAnulty JH, Mounsey P, Steinberg JS, Lancaster SE, Jadonath RL, Hallstrom AP. "Stable" Ventricular Tachycardia Is Not a Benign Rhythm : Insights From the Antiarrhythmics Versus Implantable Defibrillators (AVID) Registry. Circulation. 2001 Jan 16;103(2):244-252.

Kron J, Herre J, Renfroe EG, Rizo-Patron C, Raitt M, Halperin B, Gold M, Goldner B, Wathen M, Wilkoff B, Olarte A, Yao Q. Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial. Am Heart J. 2001 Jan;141(1):92-8.

Exner DV, Sheldon RS, Pinski SL, Kron J, Hallstrom A. Do baseline characteristics accurately discriminate between patients likely versus unlikely to benefit from implantable defibrillator therapy? Evaluation of the Canadian implantable defibrillator study implantable cardioverter defibrillatory efficacy score in the antiarrhythmics versus implantable defibrillators trial. Am Heart J. 2001 Jan;141(1):99-104.

Hallstrom AP, McAnulty JH, Wilkoff BL, Follmann D, Raitt MH, Carlson MD, Gillis AM, Shih HT, Powell JL, Duff H, Halperin BD. Patients at lower risk of arrhythmia recurrence: a subgroup in whom implantable defibrillators may not offer benefit. Antiarrhythmics Versus Implantable Defibrillator (AVID) Trial Investigators. J Am Coll Cardiol. 2001 Mar 15;37(4):1093-9.

Epstein AE. AVID necessity. Pacing Clin Electrophysiol. 1993 Sep;16(9):1773-5. No abstract available.

Zipes DP. Implantable cardioverter-defibrillator. Lifesaver or a device looking for a disease? Circulation. 1994 Jun;89(6):2934-6. No abstract available.

Hallstrom AP, Anderson JL, Cobb LA, Friedman PL, Herre JM, Klein RC, McAnulty J, Steinberg JS. Advantages and disadvantages of trial designs: a review of analysis methods for ICD studies. AVID Investigators. Pacing Clin Electrophysiol. 2000 Jun;23(6):1029-38. Review.

Exner DV, Pinski SL, Wyse DG, Renfroe EG, Follmann D, Gold M, Beckman KJ, Coromilas J, Lancaster S, Hallstrom AP. Electrical Storm Presages Nonsudden Death : The Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. Circulation. 2001 Apr 24;103(16):2066-2071.

Hickey K, Curtis AB, Lancaster S, Larsen G, Warwick D, McAnulty J, Mitchell LB. Baseline factors predicting early resumption of driving after life-threatening arrhythmias in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. Am Heart J. 2001 Jul;142(1):99-104.

Akiyama T, Powell JL, Mitchell LB, Ehlert FA, Baessler C. Resumption of driving after life-threatening ventricular tachyarrhythmia. N Engl J Med. 2001 Aug 9;345(6):391-7.

Smith TW. Driving after ventricular arrhythmias. N Engl J Med. 2001 Aug 9;345(6):451-2. No abstract available.

Wyse DG, Love JC, Yao Q, Carlson MD, Cassidy P, Greene LH, Martins JB, Ocampo C, Raitt MH, Schron E, Stamato NJ, Olarte A. Atrial fibrillation: a risk factor for increased mortality--an AVID registry analysis. J Interv Card Electrophysiol. 2001 Sep;5(3):267-73.

Steinberg JS, Martins J, Sadanandan S, Goldner B, Menchavez E, Domanski M, Russo A, Tullo N, Hallstrom A. Antiarrhythmic drug use in the implantable defibrillator arm of the Antiarrhythmics Versus Implantable Defibrillators (AVID) Study. Am Heart J. 2001 Sep;142(3):520-9.

Beumont PJ, Richards DH, Gelder MG. A study of minor psychiatric and physical symptoms during the menstrual cycle. Br J Psychiatry. 1975 May;126:431-4. No abstract available.

Wyse DG, Friedman PL, Brodsky MA, Beckman KJ, Carlson MD, Curtis AB, Hallstrom AP, Raitt MH, Wilkoff BL, Greene HL. Life-threatening ventricular arrhythmias due to transient or correctable causes: high risk for death in follow-up. J Am Coll Cardiol. 2001 Nov 15;38(6):1718-24.

Schron EB, Exner DV, Yao Q, Jenkins LS, Steinberg JS, Cook JR, Kutalek SP, Friedman PL, Bubien RS, Page RL, Powell J. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation. 2002 Feb 5;105(5):589-94.

Larsen G, Hallstrom A, McAnulty J, Pinski S, Olarte A, Sullivan S, Brodsky M, Powell J, Marchant C, Jennings C, Akiyama T. Cost-effectiveness of the implantable cardioverter-defibrillator versus antiarrhythmic drugs in survivors of serious ventricular tachyarrhythmias: results of the Antiarrhythmics Versus Implantable Defibrillators (AVID) economic analysis substudy. Circulation. 2002 Apr 30;105(17):2049-57.

Cook JR, Rizo-Patron C, Curtis AB, Gillis AM, Bigger JT Jr, Kutalek SP, Coromilas J, Hofer BI, Powell J, Hallstrom AP. Effect of surgical revascularization in patients with coronary artery disease and ventricular tachycardia or fibrillation in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Registry. Am Heart J. 2002 May;143(5):821-6.

Renfroe EG, Heywood G, Foreman L, Schron E, Powell J, Baessler C, Warwick D, Morris M, Hallstrom A. The end-of-study patient survey: methods influencing response rate in the AVID Trial. Control Clin Trials. 2002 Oct;23(5):521-33.

Raitt MH, Klein RC, Wyse DG, Wilkoff BL, Beckman K, Epstein AE, Coromilas J, Friedman PL, Martins J, Ledingham RB, Greene HL. Comparison of arrhythmia recurrence in patients presenting with ventricular fibrillation versus ventricular tachycardia in the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. Am J Cardiol. 2003 Apr 1;91(7):812-6.

Brodsky MA, Mitchell LB, Halperin BD, Raitt MH, Hallstrom AP. Prognostic value of baseline electrophysiology studies in patients with sustained ventricular tachyarrhythmia: the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial. Am Heart J. 2002 Sep;144(3):478-84.

Steinberg JS, Beckman K, Greene HL, Marinchak R, Klein RC, Greer SG, Ehlert F, Foster P, Menchavez E, Raitt M, Wathen MS, Morris M, Hallstrom A. Follow-up of patients with unexplained syncope and inducible ventricular tachyarrhythmias: analysis of the AVID registry and an AVID substudy. Antiarrhythmics Versus Implantable Defibrillators. J Cardiovasc Electrophysiol. 2001 Sep;12(9):996-1001.

Hallstrom A, Friedman L, Denes P, Rizo-Patron C, Morris M. Do arrhythmia patients improve survival by participating in randomized clinical trials?. Observations from the Cardiac Arrhythmia Suppression Trial (CAST)and the Antiarrhythmics Versus Implantable Defibrillators Trial (AVID). Control Clin Trials. 2003 Jun;24(3):341-52.

Mitchell LB, Powell JL, Gillis AM, Kehl V, Hallstrom AP; AVID Investigators. Are lipid-lowering drugs also antiarrhythmic drugs? An analysis of the antiarrhythmics versus implantable defibrillators (AVID) trial. J Am Coll Cardiol. 2003 Jul 2;42(1):81-7.

Klein RC, Schron EB, Renfroe EG, Hallstrom A, Kron J, Ocampo C, Leonen A, Tullo N; Avid Investigators. Factors determining ICD implantation in drug therapy patients after termination of antiarrythmics versus implantable defibrillators trial. Pacing Clin Electrophysiol. 2003 Dec; 26(12): 2235-40.

Klein RC, Raitt MH, Wilkoff BL, Beckman KJ, Coromilas J, Wyse DG, Friedman PL, Martins JB, Epstein AE, Hallstrom AP, Ledingham RB, Belco KM, Greene HL; AVID Investigators. Analysis of implantable cardioverter defibrillator therapy in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J Cardiovasc Electrophysiol. 2003 Sep; 14(9): 940-8.

Page RL, Zipes DP, Powell JL, Luceri RM, Gold MR, Peters R, Russo AM, Bigger JT Jr, Sung RJ, McBurnie MA; AVID Investigators. Seasonal variation of mortality in the Antiarrhythmics Versus Implantable Defibrillators (AVID) study registry. Heart Rhythm. 2004 Oct;1(4):435-40.

Study ID Numbers:	74
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000531 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Vasodilator Agents
Death
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Tachycardia
Enzyme Inhibitors
Heart Arrest
Cardiovascular Agents
Pharmacologic Actions
Amiodarone

Pathologic Processes
Therapeutic Uses
Death, Sudden
Cardiovascular Diseases
Death, Sudden, Cardiac
Anti-Arrhythmia Agents
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010