Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis

NCT ID: NCT06212050

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-06-30

Brief Summary

The goal of the NEO2 BAV registry is to investigate the safety, effectiveness, and clinical performance of TAVI using the ACURATE neo2 valve in patients with severe BAV stenosis.

The clinical, procedural, and imaging characteristics will be collected from patients with severe BAV stenosis, regardless of the phenotype, and treated with TAVI using the ACURATE neo2 bioprosthesis worldwide.

Detailed Description

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 possibility of redo-TAVI, and mortality.

The ACURATE neo2 THV has design features that make it possible to successfully treat severe BAV stenosis and yield optimal short- and longer-term outcomes. A new active sealing skirt is designed to minimize residual PVL; this is especially relevant given the presence of severe calcifications in BAV. The supra-annular leaflet position is also likely to provide excellent haemodynamics and durability since they sit above the heavily calcified native valve leaflet calcification. The upper crown and stabilizing arches and the top-down deployment of the ACURATE neo2 should reduce the risk of device embolization. It is unclear however if the self-expanding frame of the neo2 has the optimal radial force to treat patients with severe calcification.

The plan is to collect systematic clinical, procedural, and imaging data on a large series of patients with severe symptomatic BAV stenosis who underwent TAVI using the ACURATE neo2 THV. This information will show if the ACURATE neo2 is suitable to treat BAV morphology and determine if there are specific BAV subtypes that are more suitable for alternative treatment strategies. It is also envisaged that this study will inform the procedural execution of ACURATE neo2 THV in BAV morphology and inform future iteration design of the ACURATE neo THV series.

All imaging data (Echocardiography, angiography, aortography and MSCT) will be meticulously analyzed in an independent imaging Core Lab (CORRIB Core Lab, University of Galway, Galway, Ireland).

The in-depth imaging analysis will allow the identification of patients that are suitable for TAVI using the ACURATE neo2 system and highlight patient or procedural features that render TAVI at elevated risk of adverse outcomes. Furthermore, a mechanistic understanding of the device-host interaction will be examined on post-TAVI multislice computed tomography (MSCT) and other available post-TAVI imaging studies.

Conditions

Aortic Stenosis; Transcatheter Aortic Valve Implantation; Bicuspid Aortic Valve; Transcatheter Aortic Valve Replacement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with severe symptomatic BAV stenosis

Patients with severe symptomatic BAV stenosis who underwent TAVI using the ACURATE neo2 THV.

Transcatheter Aortic Valve Implantation

Intervention Type: DEVICE

TAVI in patients with severe BAV stenosis using ACURATE neo2

Interventions

Transcatheter Aortic Valve Implantation

TAVI in patients with severe BAV stenosis using ACURATE neo2

Intervention Type: DEVICE

Other Intervention Names

ACURATE neo2 Aortic valve system

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galway University Hospitals

UNKNOWN

Sponsor Role: collaborator

CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland

UNKNOWN

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Kerckhoff Heart Center

OTHER

Sponsor Role: collaborator

National University of Ireland, Galway, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Professor Osama SOLIMAN

Professor of Cardiovascular Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darren Mylotte, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Galway, Galway University Hospital

Andreas Ruck, MD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Won-Keun Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Heart and Lung Centre

Osama Soliman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Galway, Galway University Hospital

Locations

Kerckhoff Heart and Lung Centre

Bad Nauheim, , Germany

Galway University Hospital

Galway, , Ireland

Karolinska University Hospital

Stockholm, , Sweden

Countries

Germany; Ireland; Sweden

Other Identifiers

C.A. 2961

Identifier Type: -

Identifier Source: org_study_id