Aortic StenosisNCT02909556
ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
A study testing Transcatheter aortic valve replacement in people with Aortic Stenosis, run by Symetis SA at 9 sites in 3 countries.
Trial summary
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- Transcatheter aortic valve replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 16 Dec 2016to 13 Jan 2023
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient 75 years of age and older
- Severe aortic stenosis defined as:
- Mean aortic gradient > 40 mmHg or
- Peak jet velocity > 4.0 m/s or
- Aortic valve area of < 1.0 cm2
- High risk candidate for conventional AVR defined as:
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- Logistic EuroSCORE 1 ≥ 20% or
- STS Score ≥ 8% or
- Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis
- NYHA Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
- Patient willing to participate in the study and provides signed informed consent
Who cannot join
- Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- Non-stenotic Aortic Insufficiency
- Severe eccentricity of calcification
- Severe mitral regurgitation (>2+)
- Presence of mitral bioprosthesis
- Presence of previously implanted aortic bioprosthesis
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- Presence of prosthetic ring
- Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
- Thoracic (TAA) or abdominal (AAA) aortic aneurysm
- Presence of endovascular stent graft for treatment of TAA or AAA
- Trans-oesophageal echocardiogram (TEE) is contraindicated
- Evidence of intra-cardiac mass, thrombus or vegetation
- Severe ventricular dysfunction with ejection fraction < 20%
- Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- Acute Myocardial Infarction within 1 month prior to implant procedure
- Previous TIA or stroke within 3 months prior to implant procedure
- Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
- Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
- Severe coagulation conditions
- Refusal of blood transfusions
- Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
- Hypertrophic cardiomyopathy with or without obstruction
- Active bacterial endocarditis or other active infections
- Hepatic failure (> Child B)
- Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
- Refusal of surgery
- Severe COPD requiring home oxygen
- Neurological disease severely affecting ambulation or daily functioning, or dementia
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Inability to tolerate anticoagulation therapy
- Contraindication to contrast media or allergy to nickel
- Currently participating in an investigational drug or another device study
- Non-valvular aortic stenosis
- Non-calcific acquired aortic stenosis
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany7 sites
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, 61231
Johannes Hospital
Dortmund
Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie
Halle, 06120
Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, 20246
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München
München, 80636
Universitätsklinik Regensburg
Regensburg, 93053
About this study
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
Read the detailed description
Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System
The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.
The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.
The secondary objective is to evaluate adverse events and study device performance.
- Conditions
- Aortic Stenosis
- Being tested
- Transcatheter aortic valve replacement
- Keywords
- Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter aortic valve replacementDevice
Also called ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve), ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)
Transcatheter aortic valve replacement via transfemoral access
| Study group | Role | What they receive |
|---|---|---|
| ACURATE neo AS | Experimental | Not described Receives: Device: Transcatheter aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality at 30 days follow-up
Measured: 30 days post-implant
Secondary outcomes (7)
Rate of clinical events as defined per VARC guidelines
Clinical events:
- Mortality
- Stroke
- Myocardial infarction
- Bleeding complication
- Acute kidney injury
- Vascular complication
- Conduction disturbances and arrhythmia
- Other TAVI-related complications
Measured: 7 days, 30 days, 12 months post-implant
Procedural success
- Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication
Measured: Day of implant
Device success
- Device success defined as:
- Absence of intra-procedure mortality AND,
- Correct positioning of a single prosthetic heart valve into the proper anatomical location AND,
- Intended performance of the prosthetic heart valve (EOAi >0.85 cm2/m2 and mean aortic valve gradient <20mmHg without moderate or severe AR)
Measured: Day of implant
VARC Composite Safety at 30 days
Measured: 30 days
Clinical improvement from baseline as per NYHA Functional Classification
Measured: 7 days, 30 days, 12 months post-implant
Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient
Measured: 7 days, 30 days, 12 months
Total aortic regurgitation
Measured: 7 days, 30 days, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start16 Dec 2016
- Primary completion24 Jan 2018
- Study completion13 Jan 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helge Möllmann, Prof., Principal investigator, Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909556
- Sponsor's protocol ID
- 2016-01
- Status last verified
- Feb 2023
- First submitted
- 16 Sep 2016
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02909556
- Acronym / sponsor ID
- 2016-01
- Conditions
- Aortic Stenosis
- Keywords
- Transcatheter Aortic Valve Replacement, TAVI, Transcatheter Aortic Valve Implant, Transfemoral access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2016 (actual)
- Primary completion
- 24 Jan 2018 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Sep 2016 (estimated)
- 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.
Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.
Detailed description
Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System
The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.
The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.
The secondary objective is to evaluate adverse events and study device performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACURATE neo AS | Experimental | Device: Transcatheter aortic valve replacement |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Patient 75 years of age and older
- Severe aortic stenosis defined as:
- High risk candidate for conventional AVR defined as:
- NYHA Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
Key exclusion criteria (34 listed)
- Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- Non-stenotic Aortic Insufficiency
- Severe eccentricity of calcification
- Severe mitral regurgitation (>2+)
- Presence of mitral bioprosthesis
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 replacementAlso: ACURATE neo™ AS Aortic Bioprosthesis (Commercial name: ACURATE neo2™ Aortic Valve), ACURATE neo™ AS TF Transfemoral Delivery System (Commercial name: ACURATE neo2™ Transfemoral Delivery System)Transcatheter aortic valve replacement via transfemoral access | Device | ACURATE neo AS |
Primary outcome
Rate of all-cause mortality at 30 days follow-up
Time frame: 30 days post-implant
7 secondary outcomes
Rate of clinical events as defined per VARC guidelines
Time frame: 7 days, 30 days, 12 months post-implant
Procedural success
Time frame: Day of implant
Device success
Time frame: Day of implant
VARC Composite Safety at 30 days
Time frame: 30 days
Clinical improvement from baseline as per NYHA Functional Classification
Time frame: 7 days, 30 days, 12 months post-implant
Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient
Time frame: 7 days, 30 days, 12 months
Total aortic regurgitation
Time frame: 7 days, 30 days, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- 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)
Related trials for Aortic Stenosis
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Acute Pain
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Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Helge Möllmann, Prof. principal investigator
Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter aortic valve replacement in people with Aortic Stenosis, run by Symetis SA at 9 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 12 inclusion and 34 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: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Denmark, Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of all-cause mortality at 30 days follow-up (time frame: 30 days post-implant). 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 16 Feb 2023.