PPT-Clinical/Surrogate Endpoints and Innovative Approaches for Catheter Ablation Studies

FDA Perspective Marco Cannella PhD Senior Lead Reviewer Cardiac Electrophysiology Devices Branch FDA CDRH Office of Device Evaluation ISCTR Consensus Summit San Diego California September 21 2018. Sequential . thoracoscopic. and . p. ercutaneous ablation for Lone . AF . Dr. Guy Haywood. Consultant Cardiac . Electrophysiologist. South West Cardiothoracic Centre. Derriford. Hospital. Plymouth. Buttu. A.. 1. , Van . Zaen. J.. 1. , . Viso. A.. 1. , . Forclaz. A.. 2. , Pascale P.. 2. , Narayan S.. 3. , . Vesin. J.. 1. , . Pruvot. E.. 2. 1. Applied Signal Processing Group, Swiss Federal Institute of Technology EPFL, Lausanne – Switzerland. Con.. Amr Kamal, M.D. Alexandria Main University Hospital. Alexandria- Egypt. ECRA 2010. General Rules . In order to consider AF ablation as a first line therapy, we should have clear and evidence based answers for the following 5 questions:. End-points utilized in breast cancer clinical trials - Discussion Novartis Oncology Discussant - Arunava Chakravartty Stat4Onc Symposium , Hartford, CT Apr-26, 2019 Disclaimer All views expressed in the slide represent the individual views of the presenter and should not be seen as representing the views of Novartis, its board or its shareholders. (ITN). Call. : H2020-MSCA-ITN-2017. Bachelor’s degree in . Biomedical. Engineering (BME) . at. University of . Naples. “Federico II”, Italy. Thesis title : Clinical applications of Brain Computer . Avishag Laish-Farkash, MD, PhD. Director, EP and Pacing Unit, . Assuta. Ashdod University MC. Ben-Gurion University of the Negev. AF and HF – the related twin epidemics of CVD. AF is the most common cardiac arrhythmia. Generated by Mobile Technology for . Use in Clinical Trials*. *The term “clinical trial” is used here to refer to studies done to support regulatory approval for marketing. . Source: Clinical Trials Transformation Initiative’s . allowed precise location of continuous fragmented signals, which correspond to the area of slow conduction along the CTIAfter few applications of radiofrequency(RF), the arrhythmia was interrupted wi a measurable indicator . that . can . tell . us something about a person’s health or disease . state, for example, . disease (pathological) processes in the body, for example, disease stage. , . biological processes in the body (heart rate, blood pressure, temperature), . Nassir F. Marrouche, MD. , Oussama . Wazni. , MD, Tom Greene, PhD, J Michael Dean, MD, Eugene . Kholmovski. , PhD, Moussa Mansour, MD, Hugh Calkins, MD, Francis . Marchlinski. , MD, David Wilber, MD, Gerhard . Department of Electrophysiology. Hospital B. Rivadavia - CABA.Rev Argent Cardiol 2020;63:64. http://dx.doi.org/10.7775.rac.v88.i1.16486Fernando Ariel Di Tommaso, M.D. Department of Cardiac Electrophy . Natalie Dimier and Sue Todd. University of Reading. Pharm Stat. 2017 Sep;16(5):322-333. Agenda. Context. Motivation for the research. Investigation. Set-up. Results. Conclusions. Remaining Questions. RWD. Frank W. Rockhold, PhD. Professor of Biostatistics and Bioinformatics. Duke University Medical Center. Duke/Stanford CEC Summit. September 26-27, 2018, Chicago, Il. Disclosure. Statement – . clinical . trials - Discussion. Novartis Oncology. Discussant - . Arunava. . Chakravartty. Stat4Onc Symposium , . Hartford, CT . Apr-26, 2019. Disclaimer. All views expressed in the slide represent the individual views of the presenter and should not be seen as representing the views of Novartis, its board or its shareholders..