Study Protocol for Transcatheter Aortic Valve Replacement for a Degenerated Aortic Bioprosthesis in a Japanese Cohort.

The valve-in-valve (VIV) procedure is being increasingly performed in high-risk patients with a degenerated bioprosthesis in an aortic position in Western countries. The early safety and efficacy of the VIV procedure, however, remain unclear in Japanese patients with a small aortic annulus. We present the protocol for a study designed to evaluate the early safety and efficacy of the VIV procedure in the aortic position in Japanese patients. The prospective, single-center, non-comparative, clinical study of the VIV procedure for the aortic position (AORTIC VIV study) commenced in August 2016 and will end in March 2020. Patients will be monitored for ≥1 month after the VIV procedure. The targeted number of patients is 11. Eligible patients are those who have undergone transcatheter aortic valve replacement for a surgical valve (including stented or stentless bioprosthetic valves), or for a transcatheter heart valve. The VIV procedure is performed in high-operative-risk patients with substantial prosthetic valve stenosis, and regurgitation and heart failure resistant to medical treatment (unless the patient meets an exclusion criterion). The safety and efficacy of the VIV procedure will be evaluated in accordance with the Valve Academic Research Consortium-2 initiative. The AORTIC VIV study will clarify the early safety and efficacy of the VIV procedure in Japanese patients.