ObjectiveTo preliminarily explore the safety and efficacy of the Docs Valve transcatheter aortic valve replacement system. MethodsA total of 26 healthy adult sheep were selected and divided into an experimental group (n=18) and a control group (n=8). The experimental group underwent transcatheter aortic valve implantation (TAVI) via the transfemoral vascular approach, and were further subdivided into acute and chronic subgroups based on the timing of examination and anatomical exploration. Animals in the acute subgroup received anatomical exploration immediately postoperatively, while those in the chronic subgroup underwent the same exploration at 1, 3, and 6 months postoperatively. Valve position, paravalvular leak (PVL), and artificial valve leaflet tissue were observed at immediately post-operation (n=5), 1 month post-operation (n=2), 3 months post-operation (n=2), and 6 months post-operation (n=9). The control group received surgical replacement with a biological prosthetic valve, with corresponding examinations performed at 6 months postoperatively. The safety and efficacy of the valve system were analyzed using echocardiography, anatomical examination, and pathological examination. Results Seventeen sheep in the experimental group successfully completed TAVI, and 4 sheep in the control group successfully underwent surgical replacement, all surviving to the final observation period. During follow-up, valve morphology and position were normal, ultrasound imaging was clear, and the trends of changes in hemodynamics and left ventricular function were similar between the two groups. In the experimental group, 4 cases (4/17) of moderate paravalvular leakage occurred during follow-up; in the control group, 2 cases (2/4) of moderate paravalvular leakage and 1 case (1/4) of moderate regurgitation were noted. Anatomical examination revealed no thrombi, vegetations, or calcifications in either group; extensive endothelialization was observed on stents and valve leaflets, with a small amount of calcium deposition in the experimental group. Pathological examination showed no thrombus formation in core organs or brain tissues in either group. ConclusionThe results of this animal control trial preliminarily confirm the safety and efficacy of the Docs Valve transcatheter aortic valve replacement system. However, due to the limited sample size of the control group, the conclusions require further verification in larger sample sizes.