Aortic Valve StenosisNCT06959862
ACURATE Enhance Post Market Study
An observational study of Aortic Valve Stenosis and Aortic Valve Calcification, run by Boston Scientific Corporation.
Trial summary
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed. Read more about this study
- Who is it for?
- Any age
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Apr 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with symptomatic heart disease due to severe native calcific aortic stenosis
Who may be able to join
- Subject has documented severe aortic stenosis and an aortic annulus size compatible with the ACURATE neo2 valve per the commercial IFU based on the center's assessment of pre-procedure diagnostic imaging, and is deemed suitable for treatment with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) as confirmed by the Case Review Committee [CRC].
- Subject (or legal representative) understands the study requirements and provides written informed consent (eg, IEC-approved ICF).
- Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all study required follow-up visits.
Who cannot join
- Subject has a previously implanted bioprosthesis in the aortic position.
- Subject has a unicuspid or bicuspid aortic valve.
- Subject has either of the following:
- Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
- Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVI prosthesis.
- Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or to the individual components of the study valve (nickel, titanium, processed porcine pericardium, polyethylene terephthalate [PET]).
- Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- Subject is unwilling or unable to undergo study required follow-up visits.
About this study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
Read the detailed description
ACURATE Enhance is a prospective, open-label, single-arm, multicenter, post-market study in patients implanted with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) for the treatment of severe calcific aortic stenosis in a routine clinical setting.
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 ACURATE neo2 Delivery System. Up to 150 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 6 months and 1 year post index procedure per standard of care. Visits are in-person at 30 days and 1 year. The 6 month visits is in-person (preferred) or via telephone interview.
- 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 Endpoint:
Proportion of patients who achieve target valve frame expansion* at the end of the index procedure when following optimized procedural steps.
- "Target valve frame expansion" is defined as visual evidence of parallel commissure posts, as confirmed by an independent core laboratory evaluation of procedural angiogram.
Measured: Index procedure
Secondary outcomes (1)
Secondary Endpoint
All-cause mortality (cardiovascular and non-cardiovascular), Stroke (disabling and non-disabling) and Rehospitalization* at 30 days.
- Rehospitalization refers to procedure-related or valve-related hospitalization, and includes the following as defined by VARC-3: hospitalization for new complications, bioprosthetic valve dysfunction (such as valve thrombosis, endocarditis, structural valve deterioration, or non-structural valve dysfunction), or heart-failure related hospitalizations.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study startMay 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionApr 2027 (estimated)
Why it stopped: Boston Scientific made the decision to discontinue worldwide commercialization of the ACURATE valve platform.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Rück, Principal investigator, Karolinska Universitetssjukhuset, Enheten för kardiologi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959862
- Sponsor's protocol ID
- S2532
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2025
- Last updated
- 24 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)
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE Enhance Post Market Study
- ClinicalTrials.gov ID
- NCT06959862
- Acronym / sponsor ID
- S2532
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Boston Scientific made the decision to discontinue worldwide commercialization of the ACURATE valve platform.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 May 2025 (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 objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
Detailed description
ACURATE Enhance is a prospective, open-label, single-arm, multicenter, post-market study in patients implanted with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) for the treatment of severe calcific aortic stenosis in a routine clinical setting.
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 ACURATE neo2 Delivery System. Up to 150 subjects will be enrolled.
Follow-up will occur at pre-discharge, 30 days, 6 months and 1 year post index procedure per standard of care. Visits are in-person at 30 days and 1 year. The 6 month visits is in-person (preferred) or via telephone interview.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with symptomatic heart disease due to severe native calcific aortic stenosis
Key inclusion criteria (3 listed)
- Subject has documented severe aortic stenosis and an aortic annulus size compatible with the ACURATE neo2 valve per the commercial IFU based on the center's assessment of pre-procedure diagnostic imaging, and is deemed suitable for treatment with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) as confirmed by the Case Review Committee [CRC].
- Subject (or legal representative) understands the study requirements and provides written informed consent (eg, IEC-approved ICF).
- Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all study required follow-up visits.
Key exclusion criteria (8 listed)
- Subject has a previously implanted bioprosthesis in the aortic position.
- Subject has a unicuspid or bicuspid aortic valve.
- Subject has either of the following:
- Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or to the individual components of the study valve (nickel, titanium, processed porcine pericardium, polyethylene terephthalate [PET]).
- Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
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 Endpoint:
Time frame: Index procedure
Proportion of patients who achieve target valve frame expansion* at the end of the index procedure when following optimized procedural steps. * "Target valve frame expansion" is defined as visual evidence of parallel commissure posts, as confirmed by an independent core laboratory evaluation of procedural angiogram.
1 secondary outcome
Secondary Endpoint
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- 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.
Andreas Rück principal investigator
Karolinska Universitetssjukhuset, Enheten för kardiologi
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.
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 8 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: withdrawn, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 Endpoint: (time frame: Index procedure). 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 24 Jun 2025.