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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06212050
- Acronym / sponsor ID
- Neo2BAV / C.A. 2961
- Conditions
- Aortic Stenosis, Transcatheter Aortic Valve Implantation, Bicuspid Aortic Valve, Transcatheter Aortic Valve Replacement
- Keywords
- ACURATE neo2, Aortic stenosis, Bicuspid Aortic valve
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, 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
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe symptomatic BAV stenosis | – | Device: Transcatheter Aortic Valve ImplantationPatients with severe symptomatic BAV stenosis who underwent TAVI using the ACURATE neo2 THV. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe BAV stenosis and treated with TAVI using ACURATE neo2 THV.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Failure to obtain the patient's consent
- Failure to obtain the follow-up clinical data or cardiac imaging required for the study primary endpoints.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ImplantationAlso: ACURATE neo2 Aortic valve systemTAVI in patients with severe BAV stenosis using ACURATE neo2 | Device | Patients with severe symptomatic BAV stenosis |
Primary outcome
VARC-3 device success
Time frame: 30-Day
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:
VARC-3 early safety
Time frame: 30-Day
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
2 secondary outcomes
VARC-3 clinical efficacy (at 1 year and thereafter)
Time frame: 1-year
Valve-related long-term clinical efficacy (at 5 years and thereafter)
Time frame: 5-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided. not decided yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Mylotte, MD, PhD principal investigator
University of Galway, Galway University Hospital
Andreas Ruck, MD principal investigator
Karolinska University Hospital
Won-Keun Kim, MD principal investigator
Kerckhoff Heart and Lung Centre
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Ireland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VARC-3 device success (time frame: 30-Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.