Dr. Thourani has presented the ALIGN AR, a single arm, multicenter and non-blinded trial on the use of JenaValve in symptomatic patients with severe aortic regurgitation and high surgical risk.
Safety primary end point was a composite variables including all-cause mortality at 30 days, stroke, major bleeding, vascular complications, kidney failure, need for definite pacemaker implantation, valve intervention and paravalvular leak. The study included a total 180 patients and established a comparison against a pre-specified performance goal (PG).
Primary end point incidence for the JenaValve arm resulted 26.7%, achieving non-inferiority vs. PG (p for non- inferiority <0.0001). When looking at 30-day all-cause mortality, the JenaValve arm showed a 7.8% incidence, which resulted non-inferior vs. the pre-specified PG of 25%.
The incidence of definite pacemaker implantation was analyzed according to quarterly enrollment, revealing 30% rate for the first cases and 14% for the last (indicating increasing experience). As regards procedural safety, trivial paravalvular leak was observed in 92.2% of cases and mild leak in 7.8% at one year followup.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Presented by Vinod H. Thourani as part of the Late-Breaking Clinical Trials at TCT 2023, San Francisco, October 24, 2023.
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