Aortic StenosisTALP-FIMNCT02986737
ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
A study testing ACURATE neo™ and ACURATE TA™ LP in people with Aortic Stenosis, run by Symetis SA at 2 sites in Germany.
Trial summary
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device 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?
- ACURATE neo™ and ACURATE TA™ LP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Dec 2014to Oct 2019
- 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 > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2
- High risk candidate for conventional AVR defined as:
- STS score ≥ 10 or Multidisciplinary 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
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- Multidisciplinary heart team (cardiologist and cardiac surgeon) consensus that the transapical approach is the most suitable TAVI access route
- 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
- Extreme eccentricity of calcification
- Severe mitral regurgitation (> Grade 2)
- 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
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- 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 < 30% by ECHO
- Emergency procedure pre-implant including CAD requiring revascularization
- 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 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 or coagulopathy or refusal of blood transfusions
- Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
- Primary hypertrophic obstructive cardiomyopathy (HOCM)
- Active infection, endocarditis or pyrexia
- 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, daily functioning, or dementia
- Life expectancy < 12 months due to non-cardiac co-morbid conditions
- Contraindication to study medication, contrast media, or allergy to nitinol
- Currently participating in an investigational drug or another device study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Klinik für Herz-und Gefäßchirurgie
Hamburg, 20246
About this study
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
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™ and ACURATE TA™ LP
- 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™ and ACURATE TA™ LPDevice
ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP 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™ and ACURATE TA™ LP | Experimental | Patients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System Receives: Device: ACURATE neo™ and ACURATE TA™ LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
incidence of all cause mortality at 30 days
Measured: 30 days
Mean aortic gradient after device implantation
mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up
Measured: 7 days or Discharge
Secondary outcomes (4)
rate of clinical endpoints VARC II
rate of clinical endpoints VARC II at 30 days and 12 months
Measured: 30 days and month 12
procedural success
procedural success defined as ACURATE neo™ at intended location
Measured: procedure
device success assessed according to composite VARC 2 criteria
Device success defined as:
- ACURATE neo™ implanted in intended location
- No impingement of the mitral valve
- Normal coronary blood flow
- Insufficiency < Grade 3
- Mean aortic gradient < 20mmHg
- EOA ≥ 1.0 cm2 No further re-intervention performed on the ACURATE neo™ implant
Measured: 7 days, 30 days, 12 months
functional improvement from Baseline as per NYHA Functional Classification
functional improvement from baseline as per NYHA functional classification at 30 days and 12 months follow up
Measured: 30 days and 12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start8 Dec 2014
- Primary completion3 Mar 2015
- Study completionOct 2019
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medical device trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mirko Doss, Prof.Dr.Med, Principal investigator, Abteilung Herzchirurgie Kerckhoff-Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986737
- Sponsor's protocol ID
- 2014-02
- Acronym
- TALP-FIM
- Status last verified
- Apr 2020
- First submitted
- 6 Dec 2016
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE Neo™ Aortic Bioprosthesis for Implantation Using the ACURATE TA™ LP Transapical Delivery System in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT02986737
- Acronym / sponsor ID
- TALP-FIM / 2014-02
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Aortic Stenosis, Transcatether Aortic Valve Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2014 (actual)
- Primary completion
- 3 Mar 2015 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 8 Dec 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.
Trial of ACURATE neo(TM) Aortic Bioprosthesis for Implantation using the ACURATE TA(TM) LP Transapical Delivery System in Patients with Severe Aortic Stenosis for evaluating the Safety and performance of the study device
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medical device trial
| Arm | Type | Receives |
|---|---|---|
| ACURATE neo™ and ACURATE TA™ LP | Experimental | Device: ACURATE neo™ and ACURATE TA™ LPPatients implanted with ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patient 75 years of age and older
- Severe aortic stenosis defined as:
- Mean aortic gradient > 40mmHg or o Peak jet velocity > 4.0m/sor Aortic valve area of < 1.0cm2
- High risk candidate for conventional AVR defined as:
- STS score ≥ 10 or Multidisciplinary 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
Key exclusion criteria (30 listed)
- Congenital unicuspid or bicuspid aortic valve
- Extreme eccentricity of calcification
- Severe mitral regurgitation (> Grade 2)
- 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™ and ACURATE TA™ LPACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP 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™ and ACURATE TA™ LP |
Primary outcome
All cause mortality
Time frame: 30 days
incidence of all cause mortality at 30 days
Mean aortic gradient after device implantation
Time frame: 7 days or Discharge
mean aortic gradient evaluated by echocardiography and by the site at 7days or discharge per standard post-implantation follow-up
4 secondary outcomes
rate of clinical endpoints VARC II
Time frame: 30 days and month 12
procedural success
Time frame: procedure
device success assessed according to composite VARC 2 criteria
Time frame: 7 days, 30 days, 12 months
functional improvement from Baseline as per NYHA Functional Classification
Time frame: 30 days and 12 months follow up
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 9 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Mirko Doss, Prof.Dr.Med principal investigator
Abteilung Herzchirurgie Kerckhoff-Klinik
2 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™ and ACURATE TA™ LP in people with Aortic Stenosis, run by Symetis SA at 2 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 9 inclusion and 30 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
All cause mortality (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?
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 9 Apr 2020.