Real-World Study of Transcatheter Aortic Valve Replacement for Severe Aortic Valve Regurgitation

What this Trial Is About

This research aims to evaluate the safety and effectiveness of transcatheter aortic valve replacement TAVR in treating patients with pure severe native aortic valve regurgitation NAVR, a condition where the aortic valve does not close properly. NAVR is a serious heart valve disease with limited treatment options since many patients at high surgical risk do not undergo the recommended surgical valve replacement. The study seeks to provide real-world data on TAVR use in this patient group, including those with different valve anatomies, and addresses the need for less invasive alternatives. The study will enroll 500 patients diagnosed with severe NAVR who are eligible for TAVR therapy. Participants will undergo TAVR using current devices, with follow-up visits occurring around the time of the procedure and then at 1 month, 1 year, 2 years, 3 years, 4 years, 5 years, and 10 years. The study is observational, so treatments will be monitored without altering standard care. Data on procedural success, safety, and clinical outcomes will be collected over these time points. During the study, researchers will collect baseline patient information, procedural details, and clinical data to assess outcomes such as combined clinical efficacy and safety at multiple intervals up to 10 years. Regular follow-ups will include evaluations of device success, survival rates, and valve function. This long-term monitoring aims to provide comprehensive insights into how TAVR performs in patients with severe NAVR in routine clinical practice.

Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation