Safety and Effectiveness of Transcatheter Aortic Valve Implantation - EffecTAVI Registry

What this Trial Is About

Aortic stenosis (AS) is the most common valve disease in elderly people, with severe cases affecting about 3.4% of those aged 75 and older. Symptoms of severe AS are linked to a higher risk of death. Traditionally, surgical aortic valve replacement (SAVR) has been the standard treatment for symptomatic AS. Since 2002, transcatheter aortic valve implantation (TAVI) has offered a less invasive alternative for patients who cannot undergo surgery. Recent improvements in TAVI devices and techniques, along with better patient selection, have expanded its use and improved safety. This observational study, called the EffecTAVI Registry, is conducted by the University of Naples Federico II to collect information on patients with symptomatic severe AS undergoing TAVI. The study collects clinical and procedural data as well as echocardiographic results. TAVI procedures may use various arterial access points, including transfemoral, transapical, trans-subclavian, or trans-aortic routes. The study follows patients over time to evaluate outcomes. Participants will be monitored with clinical follow-ups at 30 days, 6 months, and one year after TAVI. Data on adverse events, including mortality, neurological events, bleeding, and valve complications, are recorded according to standardized criteria. All patient data are securely stored in an anonymous web-based database. The study aims to provide detailed information on the safety and effectiveness of TAVI in real-world patients with severe AS, helping guide future care.

EffecTAVI Registry