Key result
Prospective ROUTE registry evaluates TAo-TAVI 30-day mortality and complication rates.
Observational (n=300)
Yes
The ROUTE registry is designed to evaluate the real-world 30-day mortality and safety of transaortic TAVI using the Edwards SAPIEN valve in patients with severe calcific aortic stenosis.
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Prospective registry will report real-world transaortic TAVI safety; leaves open comparative efficacy versus other access routes.
BACKGROUND: Transaortic transcatheter aortic valve implantation (TAo-TAVI) is a recently developed approach that provides an alternative delivery route for valve replacement in patients with vascular abnormalities or existing comorbidities. While initial studies have shown the principal efficacy and safety, the real world effectiveness and safety of this approach remains to be fully assessed. METHODS/DESIGN: In this regard, the Registry Of the Utilization of the TAo-TAVI approach using the Edwards SAPIEN Valve (ROUTE) represents the first multicenter, multinational prospective documentation of the course and outcome of patients with severe calcific aortic stenosis (AS) undergoing TAo-TAVI. ROUTE commenced in February 2013 with the goal of consecutively enrolling 300 patients at up to 22 sites across Europe. The primary objective of ROUTE is to determine the 30-day mortality associated with TAo-TAVI using the Edwards SAPIEN THV (Edwards Lifesciences, Irvine, CA). In addition, ROUTE aims to quantify complications, predictors of patient outcome and the value of CT guided valve sizing. DISCUSSION: Findings from this landmark registry will provide important information regarding procedural success rates and early mortality in patients undergoing TAo-TAVI. TRIAL REGISTRATION: Identifier: NCT01991431.
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Bramlage et al. (2014) conducted an observational in Severe calcific aortic stenosis (n=300). Transaortic transcatheter aortic valve implantation (TAo-TAVI) was evaluated on 30-day mortality. The ROUTE registry is a planned multicenter, prospective observational study designed to determine the 30-day mortality and complication rates of transaortic transcatheter aortic valve implantation.
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