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(Circulation. 1995;91:2097-2109.)
© 1995 American Heart Association, Inc.

Articles

Clinical Investigation of Antiarrhythmic Devices

A Statement for Healthcare Professionals From a Joint Task Force of the American Heart Association, the North American Society of Pacing and Electrophysiology, the American College of Cardiology, and the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology Based on Proceedings of the Policy Conference Held November 15-16, 1993, Washington, DC

Sanjeev Saksena, MD, Chair

Key Words: arrhythmias • pacemakers • antiarrhythmia agents • AHA Medical/Scientific Statements

	Introduction

 
Cardiac pacemakers, implantable cardioverter-defibrillators, and electrode catheter systems are essential for the treatment of patients with cardiac arrhythmias. The widespread and rapidly expanding use of these antiarrhythmic devices has focused attention on the need for thorough, efficient, and practical assessment of their safety, efficacy, and clinical usefulness. In general, the effectiveness of these devices is well documented. Their capabilities may be enhanced through incorporation of existing technology and future innovations, and it is anticipated that the range of clinical indications requiring intervention and the demand for use of antiarrhythmic devices will continue to grow.

A multidisciplinary policy conference was held November 15 and 16, 1993, in Washington, DC, to facilitate formal communication among interested parties involved in the development and use of antiarrhythmic devices. Participants included representatives of divisions of the Food and Drug Administration (FDA) responsible for overseeing the pre–market release evaluation and post–market release surveillance of antiarrhythmic devices and the Health Industry Manufacturers Association, representing the device manufacturing industry.

This statement focuses on the types of clinical evaluation necessary for commercial release and subsequent assessment of antiarrhythmic devices. Generally the term clinical investigation describes the broad area of scientific studies pertaining to human pathophysiology and therapeutics. In this report, the term clinical evaluation refers to a specific class of clinical investigations performed as part of a government-mandated biomedical regulatory mission (Fig 1).

View larger version (25K): [in this window] [in a new window]   Figure 1. Schematic diagram showing the relation between different types of clinical investigation undertaken in development of an antiarrhythmic device, its clinical application, and its . . . [Full Text of this Article]