Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Launched by NATIONAL UNIVERSITY OF IRELAND, GALWAY, IRELAND · Jan 9, 2024
Trial Information
Current as of July 22, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
As the use of TAVI in BAV anatomy expands, it is important to systematically evaluate clinical outcomes from various THV technologies among BAV patients. It is essential to consider short-, and longer-term events among patients with BAV undergoing TAVI. Short-term outcomes of interest include THV embolization, PVL, residual transvalvular gradients and patient prosthesis mismatch, aortic root rupture, the requirement for new PPI, and stroke. Longer-term term clinical events of interest include quality of life, THV durability, freedom from reintervention, maintained coronary access, the possi...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients aged ≥ 18 years
- • Patients with severe AS and any BAV phenotype and indicated for TAVI based on the local heart team decision.
- • Patient treated with ACURATE neo2 THV.
- Exclusion Criteria:
- • Failure to obtain the patient's consent
- • Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.
About National University Of Ireland, Galway, Ireland
The National University of Ireland, Galway (NUI Galway) is a prestigious academic institution renowned for its commitment to research and innovation in the field of health and medicine. As a clinical trial sponsor, NUI Galway leverages its extensive expertise and resources to advance scientific knowledge and improve patient care. The university fosters collaboration among multidisciplinary teams of researchers, clinicians, and industry partners, ensuring rigorous adherence to ethical standards and regulatory compliance throughout the trial process. With a focus on translating research findings into clinical applications, NUI Galway is dedicated to enhancing health outcomes and addressing pressing medical challenges both locally and globally.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Galway, , Ireland
Stockholm, , Sweden
Bad Nauheim, , Germany
Patients applied
Trial Officials
Darren Mylotte, MD, PhD
Principal Investigator
University of Galway, Galway University Hospital
Andreas Ruck, MD
Principal Investigator
Karolinska University Hospital
Won-Keun Kim, MD
Principal Investigator
Kerckhoff Heart and Lung Centre
Osama Soliman, MD, PhD
Principal Investigator
University of Galway, Galway University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported