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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000531 |
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 |
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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 |
Study Start Date: | September 1992 |
Estimated Study Completion Date: | August 2002 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Study ID Numbers: | 74 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000531 |
Health Authority: | United States: Federal Government |
Death Heart Diseases Tachycardia Death, Sudden Paroxysmal ventricular fibrillation Heart Arrest |
Death, Sudden, Cardiac Tachycardia, Ventricular Amiodarone Ventricular Fibrillation Sotalol Arrhythmias, Cardiac |
Vasodilator Agents Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses Enzyme Inhibitors |
Cardiovascular Diseases Cardiovascular Agents Anti-Arrhythmia Agents Pharmacologic Actions |