St. Jude Medical
This article was originally published in The Gray Sheet
Executive SummaryFirm receives IDE approval from FDA to begin its Post AV Node Ablation Evaluation (PAVE) clinical trial for patients with chronic atrial fibrillation receiving an 'ablate and pace' procedure, St. Jude announces Aug. 22. The 600-patient, 65-center study will compare the effects of left ventricular or biventricular pacing with right ventricular pacing, which is the current standard of care. The study, which will use St. Jude's Frontier stimulation device and Aescula left heart lead, will randomize patients to one of three arms. Patients in the left ventricular arm will also receive a right ventricular lead to provide backup right ventricular pacing. Endpoints include the six-minute walk test and quality of life assessment
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