Passar para o conteúdo principal QP ExCELs Protego ProMRI AFFIRM ProMRI (Phase B) ProMRI (Phase C) EchoCRT ECOST IN-TIME TRUST CELESTIAL GALAXY Matrix IMPACT Replace BIO Guard-MI BIO Women BIO Continue ENERGY PEPPER DELUX PEBSI ISAR-DESIRE 4 BIOFLEX-I 4EVER BERN PEACE TASC D II TASC D Registry BIOLUX P-I BIOLUX P-II DEBAS-I BIOSOLVE-I BIOSOLVE-II BIO-RESORT SCAAR BIOFLOW-III BIOSCIENCE BIOFLOW-I ORIENT SORT OUT VII BIOFLOW-II BIOFLOW-V TREINAMENTO E EDUCAÇÃO MANUAL LIBRARY HOME MONITORING SERVICE CENTER MRI SYSTEM CHECK PROGRAMMER SOFTWARE CYBERSECURITY PRODUCT PERFORMANCE REPORT PRODUTOS CARREIRAS SALA DE IMPRENSA CONTACT PT CELESTIAL Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry Study Design Multi-center, prospective, non-randomized, FDA reviewed, observational study1 Designed to gather long-term safety and reliability data on BIOTRONIK’s Corox BP LV leads 2,499 patients at 97 USA centers - This study is ongoing Key Result The CELESTIAL registry focuses primarily on the performance of Corox leads (n=2,499), however, the majority of patients received a CRT-D system including a Linox or Linoxsmart ICD lead (n=1,843)Recent publication1 with results from the ongoing GALAXY and CELESTIAL studies demonstrate favorable lead survival probabilities Clinical Relevance Linox and Linoxsmart ICD leads are safe, reliable and infrequently associated with lead-related adverse events (AEs) Estimated cumulative survival probability is favorable and well within industry standards Scientifically sound analysis due to multi-center, high enrollment, prospective study design as well as adjudication of AEs by an independent panel of five EPs Most extensive description of performance, safety and longevity of Linox ICD leads published to date 1° Endpoints To evaluate the overall incidence of serious adverse events related to the Corox BP LV leads To evaluate the incidence of each type of serious adverse event that contributes to the above point 2° Endpoints Successful biventricular pacing in a BIOTRONIK CRT device at scheduled CELESTIAL registry follow-up through 5 years post-enrollment Serious adverse event rates for SAEs excluded from primary safety endpoint through 5 years post-enrollment Pacing threshold, sensing, and impedance measurements for Corox BP leads at scheduled CELESTIAL registry follow-up through 5 years post-enrollment Clinical Sites 99 centers, 78 active Sample Size 2,499 patients Inclusion Criteria Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment Able to understand the nature of the registry and give informed consent Available for follow-up visits on a regular basis at the investigational site Age greater than or equal to 18 years Main Exclusion Criteria Enrolled in any IDE clinical study Planned cardiac surgical procedures or interventional measures within the next 6 months Expected to receive a heart transplant within 1 year Life expectancy less than 1 year Presence of another life-threatening, underlying illness separate from their cardiac disorder Pregnancy Devices Corox OTW BP, Corox OTW-S BP, Corox OTW-L BP in conjunction with a BIOTRONIK CRT-P or CRT-D Reference no. NCT00810264 Download Section Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads Related Products CRT LEADS More Information BIOTRONIK offers high performance with safety in mind in the field of lead technology. GALAXY STUDY More Information The GALAXY study, a multi-center, prospective FDA reviewed designed to monitor the real world performance of BIOTRONIK leads. 1 Good ED, Cakulev I, Orlov MV, Hirsh D, Similes J, Mohr K, Moll P, Bloom H; Long-Term Evaluation of Biotronik Linox and Linoxsmart Implantable Cardioverter Defibrillator Leads; J Cardiovasc Electrophysiol 2016 [epub]; DOI: 10.1111/jce.12971 FOLLOW US TWITTER YOUTUBE LINKEDIN LEARN MORE ORSIRO 360°CRT HEART MONITORING MAGMARIS HOME MONITORING SERVICE CENTER GENERAL TERMS AND CONDITIONS CONFIGURAÇÕES DE COOKIES IMPRINT LEGAL DISCLAIMER PRIVACY STATEMENT