Antiarrhythmics Versus Implantable Defibrillators (AVID)

NCT00000531 | Completed Phase 3

• 1 other identifier: 74
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Interventions

defibrillators, implantable DEVICE

amiodarone amiodarone DRUG

sotalol DRUG

Eligibility Criteria

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

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.

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (52)

• Hallstrom AP, Greene HL, Wyse DG, Zipes D, Epstein AE, Domanski MJ, Schron EB; AVID Investigators. Antiarrhythmics Versus Implantable Defibrillators (AVID)--rationale, design, and methods. Am J Cardiol. 1995 Mar 1;75(7):470-5.

  PMID: 7863991 BACKGROUND

• Mower MM. AVID necessity. Pacing Clin Electrophysiol. 1994 Feb;17(2):258-60; author reply 262-6. doi: 10.1111/j.1540-8159.1994.tb01381.x. No abstract available.

  PMID: 7513414 BACKGROUND

• Fogoros RN. An AVID dissent. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 1):1707-11. doi: 10.1111/j.1540-8159.1994.tb03736.x.

  PMID: 7838777 BACKGROUND

• Connolly SJ. "An AVID dissent": commentary. Pacing Clin Electrophysiol. 1994 Nov;17(11 Pt 1):1712-3. doi: 10.1111/j.1540-8159.1994.tb03737.x.

  PMID: 7838778 BACKGROUND

• Singer I. AVID necessity. Pacing Clin Electrophysiol. 1994 Feb;17(2):260-2; author reply 262-6. doi: 10.1111/j.1540-8159.1994.tb01382.x. No abstract available.

  PMID: 7513415 BACKGROUND

• 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. doi: 10.1002/sim.4780142006.

  PMID: 8552899 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00079-9.

  PMID: 9164882 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00341-x.

  PMID: 9230158 BACKGROUND

• 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.

  PMID: 9068527 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00349-4.

  PMID: 9264422 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00394-9.

  PMID: 9285657 BACKGROUND

• Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997 Nov 27;337(22):1576-83. doi: 10.1056/NEJM199711273372202.

  PMID: 9411221 BACKGROUND

• Fogoros RN. Why the antiarrhythmics versus implantable defibrillator (AVID) trial sets the wrong precedent. Am J Cardiol. 1997 Sep 15;80(6):762-5. doi: 10.1016/s0002-9149(97)00510-9. No abstract available.

  PMID: 9315584 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• Myerburg RJ, Castellanos A. Clinical trials of implantable defibrillators. N Engl J Med. 1997 Nov 27;337(22):1621-3. doi: 10.1056/NEJM199711273372209. No abstract available.

  PMID: 9371860 BACKGROUND

• 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. doi: 10.1016/s0002-9149(97)00511-0. No abstract available.

  PMID: 9315585 BACKGROUND

• 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

  BACKGROUND

• 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. doi: 10.1097/00005650-199810000-00009.

  PMID: 9794344 BACKGROUND

• 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. doi: 10.1161/01.cir.99.13.1692.

  PMID: 10190878 BACKGROUND

• 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. doi: 10.1016/s0735-1097(99)00327-7.

  PMID: 10520795 BACKGROUND

• 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. doi: 10.1016/s0735-1097(99)00305-8.

  PMID: 10520799 BACKGROUND

• Causes of death in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J Am Coll Cardiol. 1999 Nov 1;34(5):1552-9. doi: 10.1016/s0735-1097(99)00376-9.

  PMID: 10551706 BACKGROUND

• 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. doi: 10.1016/s0735-1097(99)00234-x.

  PMID: 10440140 BACKGROUND

• 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. doi: 10.1016/s0002-8703(00)90011-5.

  PMID: 10783213 BACKGROUND

• Raitt MH, Renfroe EG, Epstein AE, McAnulty JH, Mounsey P, Steinberg JS, Lancaster SE, Jadonath RL, Hallstrom AP; Antiarrhythmics Versus Implantable Defibrillators investigators. "Stable" ventricular tachycardia is not a benign rhythm : insights from the antiarrhythmics versus implantable defibrillators (AVID) registry. Circulation. 2001 Jan 16;103(2):244-52. doi: 10.1161/01.cir.103.2.244.

  PMID: 11208684 BACKGROUND

• 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. doi: 10.1067/mhj.2001.111261.

  PMID: 11136492 BACKGROUND

• 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. doi: 10.1067/mhj.2001.111768.

  PMID: 11136493 BACKGROUND

• Hallstrom AP, McAnulty JH, Wilkoff BL, Follmann D, Raitt MH, Carlson MD, Gillis AM, Shih HT, Powell JL, Duff H, Halperin BD; Antiarrhythmics Versus Implantable Defibrillator (AVID) Trial Investigators. 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. doi: 10.1016/s0735-1097(00)01208-0.

  PMID: 11263614 BACKGROUND

• Epstein AE. AVID necessity. Pacing Clin Electrophysiol. 1993 Sep;16(9):1773-5. doi: 10.1111/j.1540-8159.1993.tb01808.x. No abstract available.

  PMID: 7692406 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.2000.tb00892.x.

  PMID: 10879390 BACKGROUND

• Exner DV, Pinski SL, Wyse DG, Renfroe EG, Follmann D, Gold M, Beckman KJ, Coromilas J, Lancaster S, Hallstrom AP; AVID Investigators. Antiarrhythmics Versus Implantable Defibrillators. Electrical storm presages nonsudden death: the antiarrhythmics versus implantable defibrillators (AVID) trial. Circulation. 2001 Apr 24;103(16):2066-71. doi: 10.1161/01.cir.103.16.2066.

  PMID: 11319196 BACKGROUND

• 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. doi: 10.1067/mhj.2001.115787.

  PMID: 11431664 BACKGROUND

• Akiyama T, Powell JL, Mitchell LB, Ehlert FA, Baessler C; Antiarrhythmics versus Implantable Defibrillators Investigators. Resumption of driving after life-threatening ventricular tachyarrhythmia. N Engl J Med. 2001 Aug 9;345(6):391-7. doi: 10.1056/NEJM200108093450601.

  PMID: 11496849 BACKGROUND

• Smith TW. Driving after ventricular arrhythmias. N Engl J Med. 2001 Aug 9;345(6):451-2. doi: 10.1056/NEJM200108093450609. No abstract available.

  PMID: 11496857 BACKGROUND

• 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. doi: 10.1023/a:1011460631369.

  PMID: 11500581 BACKGROUND

• Steinberg JS, Martins J, Sadanandan S, Goldner B, Menchavez E, Domanski M, Russo A, Tullo N, Hallstrom A; AVID Investigators. 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. doi: 10.1067/mhj.2001.117129.

  PMID: 11526368 BACKGROUND

• 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. doi: 10.1192/bjp.126.5.431. No abstract available.

  PMID: 1168516 BACKGROUND

• Wyse DG, Friedman PL, Brodsky MA, Beckman KJ, Carlson MD, Curtis AB, Hallstrom AP, Raitt MH, Wilkoff BL, Greene HL; AVID Investigators. 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. doi: 10.1016/s0735-1097(01)01597-2.

  PMID: 11704386 BACKGROUND

• 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. doi: 10.1161/hc0502.103330.

  PMID: 11827924 BACKGROUND

• Larsen G, Hallstrom A, McAnulty J, Pinski S, Olarte A, Sullivan S, Brodsky M, Powell J, Marchant C, Jennings C, Akiyama T; AVID Investigators. 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. doi: 10.1161/01.cir.0000015504.57641.d0.

  PMID: 11980684 BACKGROUND

• Cook JR, Rizo-Patron C, Curtis AB, Gillis AM, Bigger JT Jr, Kutalek SP, Coromilas J, Hofer BI, Powell J, Hallstrom AP; AVD Investigators. 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. doi: 10.1067/mhj.2002.121732.

  PMID: 12040343 BACKGROUND

• Renfroe EG, Heywood G, Foreman L, Schron E, Powell J, Baessler C, Warwick D, Morris M, Hallstrom A; AVID Coordinators and Investigators. Antiarrhythmics Versus Implantable Defibrillators. The end-of-study patient survey: methods influencing response rate in the AVID Trial. Control Clin Trials. 2002 Oct;23(5):521-33. doi: 10.1016/s0197-2456(02)00225-8.

  PMID: 12392866 BACKGROUND

• Raitt MH, Klein RC, Wyse DG, Wilkoff BL, Beckman K, Epstein AE, Coromilas J, Friedman PL, Martins J, Ledingham RB, Greene HL; Antiarrhythmics Versus Implantable Defibrillators Investigators. 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. doi: 10.1016/s0002-9149(03)00015-8.

  PMID: 12667566 BACKGROUND

• Brodsky MA, Mitchell LB, Halperin BD, Raitt MH, Hallstrom AP; AVID Investigators. 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. doi: 10.1067/mhj.2002.125502.

  PMID: 12228785 BACKGROUND

• 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. doi: 10.1046/j.1540-8167.2001.00996.x.

  PMID: 11573709 BACKGROUND

• Hallstrom A, Friedman L, Denes P, Rizo-Patron C, Morris M; CAST Investigators; AVID Investigators. 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. doi: 10.1016/s0197-2456(03)00002-3.

  PMID: 12757998 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00498-4.

  PMID: 12849664 BACKGROUND

• 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. doi: 10.1111/j.1540-8159.2003.00353.x.

  PMID: 14675006 BACKGROUND

• 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. doi: 10.1046/j.1540-8167.2003.01554.x.

  PMID: 12950538 BACKGROUND

• 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. doi: 10.1016/j.hrthm.2004.06.001.

  PMID: 15851196 BACKGROUND

• Zipes DP. Implantable cardioverter-defibrillator. Lifesaver or a device looking for a disease? Circulation. 1994 Jun;89(6):2934-6. doi: 10.1161/01.cir.89.6.2934. No abstract available.

  PMID: 8205712 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Defibrillators, Implantable; Amiodarone; Sotalol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Alfred Hallstrom

  University of Washington

Study Design

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

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: September 1, 1992
• Study Completion: August 1, 2002
• Last Updated: April 14, 2016

Record last verified: 2005-05