Condition: Severe Aortic Valve Stenosis · Valvular Heart Disease · Aortic Valve Stenosis · Sponsor: Fundación EPIC
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
This description comes directly from the study's public registry record.
RAUL MORENO GOMEZ, MD, PhD · 0034917277000 · raulmorenog@hotmail.com
FUNDACION EPIC · 0034987876135 · iepic@fundacionepic.org
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| Hospital Universitario La Paz | Fuencarral-El Pardo, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07566624