Study | Trial/Registry | Study Type | Number of patients with TAVR/SAVR | TAVR Valve Type | Country (# of centers) | Follow-up time (years) | Time Frame | Surgical Risk |
Makkar et al. 2020 | PARTNER-2 | RCT | 1011/1021 | TAVR: 100% Sapien XT SAVR: Not discussed | US and Canada (57) | 5 | December 2011 - November 2013 | Intermediate |
Tzamalis et al. 2020 | Karlsruhe Registry | Observational (propensity matched) | 216 / 216 | 37.5% Sapien 43.5% Sapien XT 16.7% CoreValve 1.4% Symetic Accurate 1.3% Jenna Valve SAVR: 34.3% Hancock, 22.7% SJM, 0.5% Mitroflow, 1.9% ATS, 40.7% Perimount | Germany (1) | 6 | April 2008 - April 2012 | Intermediate and low risk |
Sondergaard et al 2019 | NOTION | RCT, unblinded | 139/135 | TAVR: 100% first-generation CoreValve SAVR: Any bioprosthetic aortic valve (27% Mosaic, 29% Epic, 24% Trifecta, 10% Perimount, and 10% Sorin Mitroflow) | Denmark, Sweden (3) | 6 | December 2009 - April 2013 | All-comers mostly at lower risk |
Gleason et al. 2018 | CoreValve U.S. Pivotal High-Risk Trial | RCT | 391/359 | TAVR: 100% Core Valve SAVR: biological valve (98.6%), mechanical valve (1.4%). | USA (45) | 5 | February 2011 - September 2012 | High |
Mack et al. 2015 | PARTNER-1A | RCT | 348 / 351 | 100% Sapien SAVR: not discussed | Canada (2) Germany (1) USA (22) | 5 | May 2007 - August 2009 | High |