St Jude modifies HF (heart failure) device study:
This article was originally published in Clinica
The US FDA has given St Jude Medical permission to reduce the required sample size in a trial of its cardiac resynchronisation device for treating heart failure (HF) patients who are also at risk of dangerously fast heart rhythms. The study, called RHYTHM, will now require six-month follow-up data on a minimum of 126 patients implanted with St Jude's Epic HF Model V-338 ICD, as opposed to 276 patients. The St Paul, Minnesota firm said it expected to complete the enrolment phase of study in early 2003 and to receive US regulatory approval of the device in early 2004.