Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis (Neo2BAV)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Stenosis; Transcatheter Aortic Valve Replacement; Bicuspid Aortic Valve; Transcatheter Aortic Valve Implantation
• Intervention / Treatment: Device: Transcatheter Aortic Valve Implantation

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany
    • Kerckhoff Heart and Lung Centre
• Ireland
  • Galway, Ireland
    • Galway University Hospital
• Sweden
  • Stockholm, Sweden
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with severe BAV stenosis and treated with TAVI using ACURATE neo2 THV.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with severe symptomatic BAV stenosis; Patients with severe symptomatic BAV stenosis who underwent TAVI using the ACURATE neo2 THV.	Device: Transcatheter Aortic Valve Implantation; TAVI in patients with severe BAV stenosis using ACURATE neo2; Other Names: ACURATE neo2 Aortic valve system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: Karolinska University Hospital; Galway University Hospitals; Kerckhoff Heart Center; CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland
• Investigators: Principal Investigator: Darren Mylotte, MD, PhD, University of Galway, Galway University Hospital; Principal Investigator: Andreas Ruck, MD, Karolinska University Hospital; Principal Investigator: Won-Keun Kim, MD, Kerckhoff Heart and Lung Centre; Principal Investigator: Osama Soliman, MD, PhD, University of Galway, Galway University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Actual): March 1, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Aortic stenosis; ACURATE neo2; Bicuspid Aortic valve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Aortic Valve Stenosis; Constriction, Pathologic; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: C.A. 2961

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No