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

Aortic Stenosis Clinical Trial

— Neo2BAV  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06212050
• Other study ID #: C.A. 2961
• Status: Enrolling by invitation
• Start date: September 15, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2024
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: June 30, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Bicuspid Aortic Valve
• Bicuspid Aortic Valve Disease
• Constriction, Pathologic
• Transcatheter Aortic Valve Implantation
• Transcatheter Aortic Valve Replacement

Intervention

Device:
• Transcatheter Aortic Valve Implantation
TAVI in patients with severe BAV stenosis using ACURATE neo2

Locations

Country	Name	City	State
Germany	Kerckhoff Heart and Lung Centre	Bad Nauheim
Ireland	Galway University Hospital	Galway
Sweden	Karolinska University Hospital	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland	CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland, Galway University Hospitals, Karolinska University Hospital, Kerckhoff Heart Center

Countries where clinical trial is conducted

Germany,  Ireland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VARC-3 device success	Number of patients with technical success.; Number of patients with death from any cause.; Number of patients with surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication.; Number of patients with intended performance of the valve (mean gradient <20 mmHg, peak velocity <3 m/s, Doppler velocity index =0.25, and less than moderate AR), defined as the presence of all of the following:	30-Day
Primary	VARC-3 early safety	Number of patients with death from any cause.; Number of patients with stroke.; Number of patients with VARC type 2-4 bleeding.; Number of patients with major vascular, access-related, or cardiac structural complication.; Number of patients with acute kidney injury stage 3 or 4.; Number of patients with moderate or severe aortic regurgitation; Number of patients with new pacemaker due to procedure related conduction abnormalities; Number of patients with surgery or intervention related to the device	30-Day
Secondary	VARC-3 clinical efficacy (at 1 year and thereafter)	Number of patients with death from any cause.; Number of patients with stroke.; Number of patients with hospitalization (procedure or Valve related causes).	1-year
Secondary	Valve-related long-term clinical efficacy (at 5 years and thereafter)	Number of patients with bioprosthetic Valve Failure (defined as: Valve related mortality OR Aortic valve re-operation/re-intervention or Stage 3 hemodynamic valve deterioration); Number of patients with stroke.; Number of patients with VARC Type 2-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents, used specifically for valve-related concerns.	5-year