Aortic StenosisNCT02950428
ACURATE Neo™ TA Delivery System in Patient With Severe Aortic Stenosis
A study testing ACURATE neo™TA Delivery System in people with Aortic Stenosis, run by Symetis SA at 7 sites in Germany.
Trial summary
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ACURATE neo™TA Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesGermany
- Study dates
- 18 Nov 2015to 3 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be at least 18 years old
- Severe aortic stenosis defined as:
- Mean aortic gradient > 40 mmHg or
- Peak jet velocity > 4.0 m/s or
- Aortic valve area of < 0.8 cm2
- High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
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- NYHA Functional Class > II
- Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:
- porcelain aorta or
- severely calcified or highly tortuous peripheral vasculature not appropriate for transfemoral transcatheter aortic valve implantation or
- vessels too small for retrograde approach or
- other anatomical conditions making transapical approach more suitable
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT or TEE
- Patient willing to participate in the study and provides signed informed consent
Who cannot join
- Congenital unicuspid or bicuspid aortic valve or non-calcified
- Extreme eccentricity of calcification
- Severe mitral regurgitation (> Grade 3)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- LV apex is not accessible via transapical access due to severe chest deformity
- Previous surgery of the LV using a patch, such as the Dor procedure
Show all 31Show fewer
- Presence of apical LV thrombus
- Calcified pericardium
- Septal hypertrophy unacceptable for transapical procedure
- Transesophageal echocardiogram (TEE) is contraindicated
- ECHO evidence of intracardiac mass, thrombus, or vegetation
- LVEF < 20% by ECHO
- Need for emergency intervention for any reason within 30 Days of scheduled procedure
- Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- Untreated clinically significant coronary artery disease requiring revascularization within 30 days before or after the study procedure
- Acute myocardial infarction within 1 month prior to implant procedure
- Previous TIA or stroke within 6 months prior to implant procedure
- Active gastrointestinal (GI) bleeding within 3 months prior to implant procedure
- Scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
- History of bleeding diathesis, coagulopathy, refusal of blood transfusions or severe anemia (Hb<8 g/dL)
- Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
- Primary hypertrophic obstructive cardiomyopathy (HOCM)
- Active infection or endocarditis
- Hepatic failure (> Child B)
- Chronic renal dysfunction with serum creatinine > 3.0 mg/dL or renal dialysis
- Neurological disease severely affecting ambulation, daily functioning, or dementia
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Intolerance to aspirin, clopidogrel, contrast media, or porcine tissue and allergy to nickel
- Pregnant or breast-feeding women
- For other severe illnesses of the patient (e.g. active carcinoma), the investigator shall decide on an individual basis whether the patient is not to be included in the study
- Currently participating in an investigational drug or another device study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Krankenhausbetriebsgesellschaft
Bad Oeynhausen, 32545
Deutsched Herzzentrum Berlin
Berlin, 13353
Martin Luther University Halle Winttenberg
Halle, 06112
Universitätklinikum Hamburg Eppendorf
Hamburg, 20246
Herzentrum Leipzig GmbH
Leipzig, 04289
University Hospital Regensburg
Regensburg, 93053
About this study
Official title: ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.
Read the detailed description
This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.
The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery Secondary objective is to evaluate adverse events and study device performance.
- Conditions
- Aortic Stenosis
- Being tested
- ACURATE neo™TA Delivery System
- Keywords
- TAVI, Aortic Stenosis, transcatether Aortic Valve Implantation
- 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.
ACURATE neo™TA Delivery SystemDevice
ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
| Study group | Role | What they receive |
|---|---|---|
| ACURATE neo™TA Delivery System | Experimental | Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System Receives: Device: ACURATE neo™TA Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety: freedom from all-cause mortality
freedom from all-cause mortality
Measured: 6 months post procedure
Primary Device Performance:Procedure success in absence of MACCE
Procedure success in absence of MACCE
Measured: 30 days post procedure
Secondary outcomes (7)
Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines
VARC 2 guidelines include different safety and efficacy endpoints like mortality, MI, stroke, etc.
Measured: 30 Days and month 12
Incidence of all cause mortality at 30 Days and 12 Months
Incidence of all cause mortality at 30 Days and 12 Months
Measured: 30 days and 12 months
Freedom from MACCE at 30 Days, 6 Months and 12 Months
Freedom from MACCE at 30 Days, 6 Months and 12 Months
Measured: 30 Days, 6 Months and 12 Months
Number of patients who have a Procedural success defined by a combination of criteria
Procedural success defined as ACURATE neo™ at intended location with
Measured: procedure
Rate of device success
Rate of device success
Measured: 7 days/ Discharge, 30 Days, 6 Months and at 12 Months
NYHA Functional Classification improvement
NYHA Functional Classification improvement
Measured: 30 Days, 6 Month and at 12 Months
Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures
Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures
Measured: 7 Days or Discharge, 30 Days, 6 Months, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start18 Nov 2015
- Primary completion17 Apr 2017
- Study completion3 Sep 2021
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 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Pr Schönburg, Prof.Dr.Med, Principal investigator, Abteilung Herzchirurgie Kerckhoff-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950428
- Sponsor's protocol ID
- 2015-01
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2016
- Last updated
- 23 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).
Publications
Conradi L, Hilker M, Kempfert J, Borgermann J, Treede H, Holzhey DM, Schrofel H, Kim WK, Schaefer U, Walther T. Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes. Eur J Cardiothorac Surg. 2018 Oct 1;54(4):762-767. doi: 10.1093/ejcts/ezy097.
PubMed 29554265
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE Neo™ TA Transapical Delivery System in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02950428
- Acronym / sponsor ID
- 2015-01
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Aortic Stenosis, transcatether Aortic Valve Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 1 Nov 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.
The purpose of this investigation is to collect data pertaining to the safety and performance of the ACURATE neo (TM) Aortic Bioprosthesis as implanted with the ACURATE neo (TM) TA Transapical Delivery System. This device is intended for treatment of subjects with severe aortic stenosis (AS) who have high risk for conventional aortic valve replacement (AVR) surgery. The ACURATE neo (TM) Aortic Bioprosthesis is intended for use via minimally-invasive transapical implantation in a well-defined population.
Detailed description
This is a single arm, prospective, multicenter non randomised and open trial of the treatment of patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be high risk. All patients will be followed up to 5 years after the intervention.
The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis considered to be high risk for surgery 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™TA Delivery System | Experimental | Device: ACURATE neo™TA Delivery SystemPatients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subject must be at least 18 years old
- Severe aortic stenosis defined as:
- High risk patient determined by a multidisciplinary heart team consensus (cardiologist and cardiac surgeon) that patient is not a surgical candidate for conventional AVR due to risk factors such as STS Score (8% or higher) or other co-morbid conditions unrelated to aortic stenosis such as severe chronic obstructive pulmonary disease (COPD), chest deformities and irradiated mediastinum
- NYHA Functional Class > II
- Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable access route for TAVI due to the presence of the following anatomic conditions:
Key exclusion criteria (31 listed)
- Congenital unicuspid or bicuspid aortic valve or non-calcified
- Extreme eccentricity of calcification
- Severe mitral regurgitation (> Grade 3)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- LV apex is not accessible via transapical access due to severe chest deformity
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 |
|---|---|---|
| ACURATE neo™TA Delivery SystemACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk | Device | ACURATE neo™TA Delivery System |
Primary outcome
Primary Safety: freedom from all-cause mortality
Time frame: 6 months post procedure
freedom from all-cause mortality
Primary Device Performance:Procedure success in absence of MACCE
Time frame: 30 days post procedure
Procedure success in absence of MACCE
7 secondary outcomes
Rate of clinical endpoints according to the Valve Academic Research Consortium (VARC 2) guidelines
Time frame: 30 Days and month 12
Incidence of all cause mortality at 30 Days and 12 Months
Time frame: 30 days and 12 months
Freedom from MACCE at 30 Days, 6 Months and 12 Months
Time frame: 30 Days, 6 Months and 12 Months
Number of patients who have a Procedural success defined by a combination of criteria
Time frame: procedure
Rate of device success
Time frame: 7 days/ Discharge, 30 Days, 6 Months and at 12 Months
NYHA Functional Classification improvement
Time frame: 30 Days, 6 Month and at 12 Months
Echocardiographic assessment of valve performance (at 7 Days or Discharge, 30 Days, 6 Months, 12 Months) using a combination of measures
Time frame: 7 Days or Discharge, 30 Days, 6 Months, 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 23 Feb 2023.
- Derived from this study: PubMed 29554265Conradi L, Hilker M, Kempfert J, Borgermann J, Treede H, Holzhey DM, Schrofel H, Kim WK, Schaefer U, Walther T. Prospective multicentre evaluation of a novel, low-profile transapical delivery system for self-expandable transcatheter aortic valve implantation: 6-month outcomes. Eur J Cardiothorac Surg. 2018 Oct 1;54(4):762-767. doi: 10.1093/ejcts/ezy097.
- 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.
Markus Pr Schönburg, Prof.Dr.Med principal investigator
Abteilung Herzchirurgie Kerckhoff-Klinik
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACURATE neo™TA Delivery System in people with Aortic Stenosis, run by Symetis SA at 7 sites in Germany.
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 14 inclusion and 31 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 23 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 7 sites in Germany. 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?
Primary Safety: freedom from all-cause mortality (time frame: 6 months post procedure). 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 NCT02950428, 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 23 Feb 2023.