In March 2013, SCAI Women in Innovations (“WIN”) will begin collecting registry data on female patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with commercially available valves and delivery systems in Europe.
The “WIN TAVI Registry” will be a multi-center, prospective, observational registry that will enroll at least 1,000 patients. The goal is to determine the safety and efficacy (according to VARC 2 and BARC definitions) of TAVI in women by way of collecting specific gender related factors not captured in other registries. These factors include data elements such as history of osteoporosis, gestational diabetes and use of oral contraceptives.
Collection of gender-specific data will address the lack of sex-based data available for study, a primary reason for the delay in finding real world solutions to health disparities. TAVI presents an excellent opportunity for collecting data on female patients, typically not well-represented in clinical trials or procedural data, as half of all TAVI procedures are performed on women. The WIN TAVI Registry aims to set a new paradigm for the study of women with heart disease by focusing the registry exclusively on this patient population.
Because it is an investigator-driven project, led by WIN Co-Chair Alaide Chieffo, MD, FSCAI and Anna Sonia Petronio, MD, WIN was thrilled to have over 30 European centers respond to the call to participate in the registry. Interested centers come from Italy, France, Germany, Spain, Latvia, the Netherlands and the UK. Patient data will be collected starting in March of 2013, with the goal of reaching 1,000 patients within one year. Data will be collected through an eCRF organized by Mount Sinai University Hospital in New York, NY, and monitoring services will be provided by the Centre Europeen de Recherche Cardiovasculaire (CERC) in Paris, France.
Though the project is currently unfunded, the goal is to attract sponsorship in order to expand the effort to other countries around the world, including the United States, allowing for greater data collection, more intricate sub-studies and site reimbursement.
To learn more about the study, please contact WIN Director Rebecca Ortega via firstname.lastname@example.org.
WIN TAVI Registry Executive Committee Members;
· Alaide Chieffo, MD (Study PI)
· Antonio Colombo, MD
· Marty Leon, MD
· Roxana Mehran, MD
· Marie Claude Morice, MD
· A. Sonia Petronio, MD (Study Co-PI)
· Alec Vahanian, MD
WIN TAVI Registry Steering Committee Members;
· Alaide Chieffo, MD (Italy)
· Thierry Lefevre, MD (France)
· Julinda Mehilli, MD (Germany)
· Roxana Mehran, MD (USA)
· Ghada Mikhail, MD (UK)
· Inga Narbute, MD (Latvia)
· A. Sonia Petronio, MD (Italy)
· Didier Tchetche, MD (France)
· Nicholas van Mieghen, MD (Netherlands)