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September 24, 2003

Ethical Aspects in Trials of Implantable Medical Devices

Author Affiliations

Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.

JAMA. 2003;290(12):1579. doi:10.1001/jama.290.12.1579-a

To the Editor: Dr Connolly and colleagues1 found that pacemaker therapy did not reduce the risk of recurrent syncope in patients with vasovagal syncope. Patients in the control group all underwent pacemaker implantation, but their pacemakers were set for sensing only, without pacing in the event of a dysrhythmia. The authors justified this nontherapeutic surgical intervention by noting that control patients could have their devices activated for pacing once the study had been completed. Although there is controversy about the ethical aspects of such sham surgery,2,3 this study is unique in that the patients were left with an implanted device.

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