Aortic StenosisNeo2BAVNCT06212050
Feasibility, Safety, and Effectiveness of the ACURATE neo2 Transcatheter Heart Valve for Severe Bicuspid Aortic Stenosis
An observational study of Aortic Stenosis and Transcatheter Aortic Valve Implantation, run by National University of Ireland, Galway, Ireland at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve
- What is being tested?
- Transcatheter Aortic Valve Implantation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Sep 2023to 30 Jun 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe BAV stenosis and treated with TAVI using ACURATE neo2 THV.
Who may be able to join
- 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.
Who cannot join
- Failure to obtain the patient's consent
- Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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
- Being tested
- Transcatheter Aortic Valve Implantation
- Keywords
- ACURATE neo2, Aortic stenosis, Bicuspid Aortic valve
- Medical subject headings
- Aortic Valve Stenosis, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ImplantationDevice
Also called ACURATE neo2 Aortic valve system
TAVI in patients with severe BAV stenosis using ACURATE neo2
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe symptomatic BAV stenosis | Patients with severe symptomatic BAV stenosis who underwent TAVI using the ACURATE neo2 THV. Receives: Device: Transcatheter Aortic Valve Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
Measured: 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
Measured: 30-Day
Secondary outcomes (2)
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).
Measured: 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.
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 Sep 2023
- Primary completion1 Mar 2024
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University College Hospital Galway, CORRIB Research Centre for Advanced Imaging and Core Lab, Galway, Ireland, Karolinska University Hospital, Kerckhoff Heart Center
- Responsible party
- Principal investigator, Professor Osama SOLIMAN, National University of Ireland, Galway, Ireland
- Investigators
- Darren Mylotte, MD, PhD, Principal investigator, University of Galway, Galway University HospitalAndreas Ruck, MD, Principal investigator, Karolinska University HospitalWon-Keun Kim, MD, Principal investigator, Kerckhoff Heart and Lung CentreOsama Soliman, MD, PhD, Principal investigator, University of Galway, Galway University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212050
- Sponsor's protocol ID
- C.A. 2961
- Acronym
- Neo2BAV
- Status last verified
- Jun 2024
- First submitted
- 8 Nov 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: not decided yet