HALO Post-Approval Study: A single arm, non-randomized, multi-center clinical study of the SJMTM Masters HPTM 15mm Rotatable Mechanical Heart Valve as aortic valve replacement therapy
Study ID: STU-2020-1194
The purpose of this study is to evaluate the safety and effectiveness of the 15mm MHV as an aortic replacement valve. The inclusion of the patients will be based on the requirement that effectiveness information (e.g., echocardiography data at a time point greater than 90 days) is available or may be acquired. The study may be conducted to either of the following two options: 1. a minimum of 20 subjects implanted with the 15mm HP aortic valve (echocardiography data reported whenever it is available); or 2. a minimum of 12 subjects with echocardiography data at a time point(s) greater than 90 days after the day of implant. all enrolled subjects will be followed yearly for five years from the date of implant, until subject withdrawal, or until end of device use, whichever occurs first. This clinical study will be conducted in up to 40 sites across the uS and 10 sites outside of the uS. Based on historical data, it is expected that approximately 3-4 new patients will be enrolled per year, for an estimated enrollment duration of 3 to 5 years. although the 15mm valve is approved without age restriction, it is expected that all subjects will be children due to the size of the implant. The two primary endpoints will be comprised of one safety and three effectiveness endpoints. The primary safety endpoint for this study is the actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced.
The primary objective of this study is to evaluate long-term safety and effectiveness of the 15mm Masters Mechanical Heart Valve (MHV) in patients with a diseased, damaged or malfunctioning aortic valve. The objective will be evaluated by assessing valve-related adverse events, subject survival and echocardiogram assessment of hemodynamic function through the five-year follow-up visit as long as the valve remains implanted.