Aortic Valve StenosisNCT04655248
ACURATE neo2™ Post Market Clinical Follow up Study
An observational study of Aortic Valve Stenosis and Aortic Valve Calcification, run by Boston Scientific Corporation at 19 sites in 8 countries.
Trial summary
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- What is being tested?
- Transcatheter Aortic Valve Implantation/Replacement
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 16 Dec 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 symptomatic heart disease due to severe native calcific aortic stenosis
Who may be able to join
- There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.
Who cannot join
- EC1. Subject has a previous bioprosthesis in the aortic position.
- EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
- EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure
- Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
Germany4 sites
Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie
Bad Nauheim
HDZ Bad Oeynhausen
Bad Oeynhausen
St.-Johannes-Hospital
Dortmund
Universitätsklinik Regensburg
Regensburg
Denmark3 sites
Aarhus Universitetshospital
Aarhus
Rigshospitalet
Copenhagen
Odense University Hospital
Odense
Italy3 sites
A.O.U Policlinico "G.Rodolico - San Marco"
Catania, CA, 95123
San Raffaele Hospital
Milan
Azienda Ospedaliera Pisana
Pisa
Spain2 sites
Hospital Clinico de Santiago
Santiago de Compostela
Hospital Clinico Universitario Valladolid
Valladolid, 47005
Sweden2 sites
Lund University, Cardiology department
Lund
Karolinska Universitetssjukhuset
Stockholm
United Kingdom2 sites
Liverpool Heart and Chest Hospital
Liverpool
John Radcliffe Hospital
Oxford
About this study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.
Read the detailed description
ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.
A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.
ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form
- Being tested
- Transcatheter Aortic Valve Implantation/Replacement
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve, Calcification of, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation/ReplacementDevice
The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint:
All-cause mortality after the index implant procedure
Measured: 30 days
Primary Imaging Endpoint:
Hypoattenuated leaflet thickening (HALT) as measured by 4D CT
Measured: 30 days
Secondary outcomes (6)
Safety endpoints adjudicated by an independent Clinical Events Committee
All-cause mortality (cardiovascular and non-cardiovascular) Stroke (disabling and non-disabling) Bleeding (life-threatening [or disabling] and major) Vascular complications (major) Hospitalization for valve-related symptoms or worsening congestive heart failure (NYHA class III or IV)
Measured: all 5 years
Additional Safety Endpoints
- Myocardial infarction (periprocedural [≤72 hours post index procedure] and spontaneous [>72 hours post index procedure])
- Acute kidney injury (≤7 days post index procedure) based on the AKIN System Stage 3 (including renal replacement therapy) and Stage 2
- Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
- New permanent pacemaker implantation resulting from new or worsened conduction disturbances
- New onset of atrial fibrillation or atrial flutter
- Coronary obstruction (≤3 days post index procedure)
- Ventricular septal perforation (≤3 days post index procedure)
- Annular rupture (≤3 days post index procedure)
- Cardiac tamponade (≤3 days post index procedure)
- Valve migration
- Valve embolization
- Ectopic valve deployment
- Transcatheter aortic valve (TAV)-in-TAV deployment
- Prosthetic aortic valve thrombosis
- Prosthetic aortic valve endocarditis
Measured: all 5 years
Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)
Effective orifice area (EOA), Mean and Peak aortic gradients, peak aortic velocity, and grade of aortic regurgitation/paravalvular leak (PVL).
Center-reported TTE measures will also be collected annually at 2 through 5 years per local standard of care for TAVI.
Measured: Discharge, 30 days, annually from year 1 to 5
EuroQoL Quality of Life questionnaire (EQ-5D-5L)
Health status as evaluated by the EQ-5D-5L Quality Of Life questionnaire
Measured: Baseline, 30-day, 1-year
New York Heart Association (NYHA) functional classification
Classification of heart failure symptoms as evaluated by NYHA classification
Measured: Baseline, Discharge, 30 days, annually from year 1 to 5
Assessments using 4D CT-scan
- Assessment of leaflet mobility
- Assessment of hypoattenuated leaflet thickening (HALT)
- Assessment of leaflet thrombosis
Measured: 30 days 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start16 Dec 2020
- Primary completion9 Mar 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won-Keun Kim, MD, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655248
- Sponsor's protocol ID
- S2410
- Status last verified
- Jun 2025
- First submitted
- 30 Nov 2020
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy. (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
Publications
Kim WK, Mollmann H, Montorfano M, Ellert-Gregersen J, Rudolph TK, Van Mieghem NM, Hilker M, Amat-Santos I, Terkelsen CJ, Petronio AS, Stella P, Gotberg M, Ruck A, Kasel AM, Trillo R, Appleby C, Barbanti M, Blanke P, Asch FM, Modolo R, Allocco DJ, Tamburino C. Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. EuroIntervention. 2024 Jan 1;20(1):85-94. doi: 10.4244/EIJ-D-23-00823.
PubMed 37982152
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE neo2™ Post Market Clinical Follow up Study
- ClinicalTrials.gov ID
- NCT04655248
- Acronym / sponsor ID
- S2410
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Dec 2020 (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 ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.
Detailed description
ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study.
A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year.
ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic heart disease due to severe native calcific aortic stenosis
Key inclusion criteria (1 listed)
- There are no specific inclusion criteria set for this post-market surveillance study. A subject must sign an IEC-approved ICF and the ACURATE neo2 Transfemoral Aortic Valve System should be used according to the commercial IFU.
Key exclusion criteria (5 listed)
- EC1. Subject has a previous bioprosthesis in the aortic position.
- EC2. Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- EC3. Subject has atrial fibrillation that cannot be rate controlled to ventricular response rate < 60 bpm.
- EC4. Subject is expected to undergo chronic anticoagulation therapy after the TAVI procedure
- Note : Subjects treated with short-term anticoagulation post-procedure can be included; in these subjects the 30-day imaging will be performed 30 days after discontinuation of anticoagulation.
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 Implantation/ReplacementThe device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU | Device | – |
Primary outcome
Primary Safety Endpoint:
Time frame: 30 days
All-cause mortality after the index implant procedure
Primary Imaging Endpoint:
Time frame: 30 days
Hypoattenuated leaflet thickening (HALT) as measured by 4D CT
6 secondary outcomes
Safety endpoints adjudicated by an independent Clinical Events Committee
Time frame: all 5 years
Additional Safety Endpoints
Time frame: all 5 years
Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)
Time frame: Discharge, 30 days, annually from year 1 to 5
EuroQoL Quality of Life questionnaire (EQ-5D-5L)
Time frame: Baseline, 30-day, 1-year
New York Heart Association (NYHA) functional classification
Time frame: Baseline, Discharge, 30 days, annually from year 1 to 5
Assessments using 4D CT-scan
Time frame: 30 days 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Derived from this study: PubMed 37982152Kim WK, Mollmann H, Montorfano M, Ellert-Gregersen J, Rudolph TK, Van Mieghem NM, Hilker M, Amat-Santos I, Terkelsen CJ, Petronio AS, Stella P, Gotberg M, Ruck A, Kasel AM, Trillo R, Appleby C, Barbanti M, Blanke P, Asch FM, Modolo R, Allocco DJ, Tamburino C. Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study. EuroIntervention. 2024 Jan 1;20(1):85-94. doi: 10.4244/EIJ-D-23-00823.
- Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy. (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
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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.
Won-Keun Kim, MD principal investigator
Kerckhoff Klinik
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Valve Calcification, run by Boston Scientific Corporation at 19 sites in 8 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 1 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Denmark, Italy, Netherlands, Spain and 3 more countries. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Safety Endpoint: (time frame: 30 days). 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?
On the ClinicalTrials.gov record for NCT04655248, which also lists 1 linked publication.
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 25 Jun 2025.