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

NCT06212050 | Enrolling By Invitation

• 1 other identifier: C.A. 2961
• Study Type: observational
• Target: 200
• Locations: 3 countries
• Sites: 3

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.

Conditions

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

Keywords

ACURATE neo2; Aortic stenosis; Bicuspid Aortic valve

Outcome Measures

Primary Outcomes (2)

• VARC-3 device success

  1. Number of patients with technical success. 2. Number of patients with death from any cause. 3. Number of patients with surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication. 4. 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

  1. Number of patients with death from any cause. 2. Number of patients with stroke. 3. Number of patients with VARC type 2-4 bleeding. 4. Number of patients with major vascular, access-related, or cardiac structural complication. 5. Number of patients with acute kidney injury stage 3 or 4. 6. Number of patients with moderate or severe aortic regurgitation 7. Number of patients with new pacemaker due to procedure related conduction abnormalities 8. Number of patients with surgery or intervention related to the device

  30-Day

Secondary Outcomes (2)

• VARC-3 clinical efficacy (at 1 year and thereafter)

  1-year

• Valve-related long-term clinical efficacy (at 5 years and thereafter)

  5-year

Study Arms (1)

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

Interventions

Transcatheter Aortic Valve Implantation DEVICE

TAVI in patients with severe BAV stenosis using ACURATE neo2

Also known as: ACURATE neo2 Aortic valve system

Patients with severe symptomatic BAV stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Failure to obtain the patient's consent
• Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead
• Galway University Hospitals: collaborator
• CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland: collaborator
• Karolinska University Hospital: collaborator
• Kerckhoff Heart Center: collaborator

Study Sites (3)

Kerckhoff Heart and Lung Centre

Bad Nauheim, Germany

Location

Galway University Hospital

Galway, Ireland

Location

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Bicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Research

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: January 18, 2024
• Study Start: September 15, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 30, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

DE (1); IE (1); SE (1)