Author(s): Nuis, Rutger Jan ; van Belle, Eric ; Teles, Rui ; Blackman, Daniel ; Veulemans, Verena ; Santos, Ignacio Amat ; Pilgrim, Thomas ; Tarantini, Giuseppe ; Saia, Francesco ; Iakovou, Ioannis ; Mascherbauer, Julia ; Vincent, Flavien ; Geleijnse, Marcel ; Sathananthan, Janarthanan ; Wood, David ; Makkar, Raj ; Van Mieghem, Nicolas M.
Date: 2023
Persistent ID: http://hdl.handle.net/10362/151020
Origin: Repositório Institucional da UNL
Subject(s): Cardiology and Cardiovascular Medicine
Funding Information: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. Publisher Copyright: © 2022 The Author(s)
Background: Surgical aortic valve bioprostheses may degenerate over time and require redo intervention. Transcatheter aortic valve replacement (TAVR) is a less invasive alternative to redo surgery. The BAlloon Expandable vs. SElf Expanding Transcatheter VaLve for Degenerated BioprosthesIs (BASELINE) trial was designed to compare the performance of the balloon-expandable SAPIEN-3 Ultra and the self-expanding EVOLUT PRO+ valve systems in symptomatic patients with a failing surgical bioprosthesis. Methods: The BASELINE trial is an investigator-initiated, non-funded, prospective, randomized, open-label, superiority trial enrolling a total of 440 patients in up to 50 sites in 12 countries in Europe and North-America. The primary endpoint is device success at 30-days defined by the Valve Academic Research Consortium-3 Criteria as the composite of technical success, freedom from mortality, freedom for surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication with an intended performance of the valve (mean gradient <20 mmHg and less than moderate aortic regurgitation). The co-primary endpoint at 1 year is defined as the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems. Independent Core Laboratories will conduct uniform analyses of echocardiography (pre-, post-, 1-year post-procedure), multi-sliced computed tomography (pre-, and if available post-procedure) and cine-fluoroscopy studies. Conclusions: The BASELINE trial is a head-to-head comparative trial investigating the 2 most used contemporary transcatheter heart valves for the treatment of a failing surgical aortic bioprosthesis. (ClinicalTrials.gov number NCT04843072).
