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Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads

Autor: Heather L. Bloom, Eric Good, Kelly Mohr, David S. Hirsh, Ivan Cakulev, Michael V. Orlov, Phil Moll, John Simeles

Publikováno v: Journal of Cardiovascular Electrophysiology. 27:735-742

Introduction Expert consensus holds that post-market, systematic surveillance of ICD leads is essential to ensure confirmation of adequate lead performance. GALAXY (NCT00836589) and CELESTIAL (NCT00810264) are ongoing multicenter, prospective, non-ra

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::7eb9717d22b8c144331f0b9aa0f454e8
https://doi.org/10.1111/jce.12971

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An evaluation of the effectiveness of a risk-based monitoring approach implemented with clinical trials involving implantable cardiac medical devices

Autor: Phil Moll, Angie Rock, Christopher A Diani

Publikováno v: Clinical trials (London, England). 14(6)

Background Risk-based monitoring is a concept endorsed by the Food and Drug Administration to improve clinical trial data quality by focusing monitoring efforts on critical data elements and higher risk investigator sites. BIOTRONIK approached this b

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6e02462187735181f0cf1f96489e5f66
https://pubmed.ncbi.nlm.nih.gov/28819983

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