The Hydra CE Study ^1,2

A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve: The Hydra CE study

Objective of the Study:

To assess the clinical performance and safety of the Hydra transcatheter aortic valve (THV) for transfemoral transcatheter aortic valve replacement (TAVR) in the treatment of patients with symptomatic severe aortic stenosis and high or extreme surgical risk.

Primary performance Endpoint:

Device success defined as per VARC II criteria:

absence of procedural mortality, AND
correct positioning of a single prosthetic heart valve into the proper anatomical location, AND
intended performance of the prosthetic heart valve (no patient-prosthesis mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation.

Primary safety endpoint:

All-cause mortality at 30 days.

Secondary performance Endpoint:

Indices of prosthetic valve function (i.e., mean gradient, effective orifice area), paravalvular leak, as well as changes in NYHA functional status and 6-minute walk test distance.

Secondary safety Endpoint:

Rates of major adverse events such as cardiovascular death, device-related death, stroke, trans-ischemic attacks, myocardial infarction, major bleeding, acute kidney injury, need for permanent pacemaker implantation, and vascular access related complications. All clinical endpoints were evaluated as per VARC-II criteria at 30-day, 1-year, 2-year, 3-year and 5-year follow-up.