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Recommendations of the NASPE Policy Conference on the Clinical Investigation of New Implantable Pacemakers

The North American Society of Pacing and Electrophysiology recommends the following guidelines for conducting clinical evaluations of new implantable cardiac pacemakers. These recommendations apply only to implantable pacemakers and not the entire pacing system or external devices. In addition, these recommendations may not be applicable for the evaluation of certain implantable devices such as tachycardia terminating pacemakers or implantable defibrillators.