Clinical trial NCT06212050: Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
Official title: Investigator Initiated Multicenter Study to Evaluate the Feasibility, Safety and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis - The Neo2 BAV Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aortic Stenosis
Transcatheter Aortic Valve Implantation
Bicuspid Aortic Valve
Transcatheter Aortic Valve Replacement
Keywords: ACURATE neo2
Aortic stenosis
Bicuspid Aortic valve
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Galway University Hospitals
name: CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
name: Karolinska University Hospital
name: Kerckhoff Heart Center
First posted: 2024-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe BAV stenosis and treated with TAVI using ACURATE neo2 THV.

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.

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.

Primary outcomes:
measure: VARC-3 device success
timeFrame: 30-Day
measure: VARC-3 early safety
timeFrame: 30-Day
Secondary outcomes:
measure: VARC-3 clinical efficacy (at 1 year and thereafter)
timeFrame: 1-year
measure: Valve-related long-term clinical efficacy (at 5 years and thereafter)
timeFrame: 5-year
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Heart and Lung Centre
city: Galway
country: Ireland
facility: Galway University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: University of Galway, Galway University Hospital
name: Darren Mylotte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital
name: Andreas Ruck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerckhoff Heart and Lung Centre
name: Won-Keun Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Galway, Galway University Hospital
name: Osama Soliman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: