Early Safety and Performance of the Premounted Dry-Pericardium Vienna Self-Expandable Transcatheter Aortic Valve System: 30-Day Outcomes of the First-in-Human VIVA Feasibility Study.

The purpose of this first-in-human (FIH) study was to determine the safety and feasibility of the transfemoral premounted dry-pericardium Vienna Self-Expandable Supra-Annular Aortic Valve System. This novel system is repositionable and retrievable and comes already premounted on the delivery system, eliminating the need for assembly and crimping of the device before valve implantation. This is a prospective, nonrandomized, single-arm, single-center, first-stage FIH feasibility study, which will be followed by a second-stage pivotal, multicenter, multinational study in symptomatic patients with severe aortic stenosis. The first-stage FIH study evaluated the safety and feasibility of the device in 10 patients with severe aortic stenosis based on recommendations by the Valve Academic Research Consortium-2 for transcatheter aortic valve implantations. The mean patient age was 79 ± 5 years, 60% were male, and all patients were in New York Heart Association functional class II to III. The primary safety end point was successful when all patients were alive at 30-day follow-up. Device and technical success were observed in all patients. Two patients had a stroke, 1 of which occurred 5 days after the procedure. New permanent pacemakers were implanted in 2 patients (22.2%), of which only 1 was because of complete heart block. Only 1 patient (10%) had moderate paravalvular leak at 30 days. After the procedure, the mean aortic valve gradient decreased from 48.7 ± 10.8 mm Hg to 8.8 ± 4.3 mm Hg. In conclusion, this FIH feasibility study demonstrates successful procedural feasibility, with no 30-day mortality and favorable valve hemodynamic performance, leading to an improvement in quality of life. ClinicalTrials.gov identifier NCT04861805.