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Initial findings from Riata Lead Evaluation Study released
Phase 1 results from the Riata Lead Evaluation Study showed that externalized conductors occurred in 9.3% of the smaller-diameter Riata ST 7F leads and in 24% of the larger-diameter Riata 8F leads, according to a press release issued by St. Jude Medical.
The Riata Lead Evaluation Study is an international, multicenter prospective study of Riata and Riata ST silicone implantable cardioverter defibrillator leads that enrolled 724 patients at 20 sites in the United States and Canada. An additional 51 patients were enrolled at three sites in Japan and results will be reported at a later date.
The study will continue to evaluate the performance of Riata leads, both with and without externalized conductors, during the next 2 years to assess their functioning over time, which may help further inform patient management considerations, according to the release.
“The rates of externalized conductors in this study are consistent with other published studies involving fluoroscopic screening of patients with Riata leads. This study also reinforces that externalized conductors are more prevalent in larger-diameter Riata leads,” Mark Carlson, MD, chief medical officer and senior vice president of clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division, said in the release.
“We are now focused on collecting longer-term data in the second phase of this study. Our goal is to provide physicians timely and relevant clinical data to best support their patient management decisions,” Carlson said.