Aortic Stenosis SymptomaticTA-FIMNCT03567278
Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis (2009-01)
A study testing ACURATE TA™ in people with Aortic Stenosis Symptomatic, run by Symetis SA at 5 sites in Germany.
Trial summary
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis Symptomatic
- What is being tested?
- ACURATE TA™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesGermany
- Study dates
- Nov 2009to Sep 2015
- 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
- Patients older than 75 years;
- Additive EuroSCORE > 9 and/or STS > 9%;
- Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²;
- NYHA Functional Class > II;
- Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;
- Sinotubular junction (STJ) higher than 1,1times the native aortic annulus diameter (AAn) [STJ>1.1xAAn] AND STJ<45mm by transoesophageal echocardiography;
- Patient understands the implications of participating in the study and provides signed informed consent
Who cannot join
- Congenital unicuspid or bicuspid aortic valve;
- Severe eccentricity of calcification;
- Severe mitral regurgitation (> 2°);
- Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
- Severe transapical access problem, non-reachable LV apex;
- Previous surgery of the LV using a patch, such as the Dor procedure;
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- Presence of apical LV thrombus;
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation;
- Acute Myocardial Infarction (AMI) within 1 month prior to the procedure;
- PCI within 1 month prior to the procedure;
- Previous Transient Ischemic Accident (TIA) or stroke in the last 3 months;
- Untreated clinically significant CAD requiring revascularization;
- Hemodynamic instability: systolic pressure <90mmHg without afterload reduction, shock, need for inotropic support or intra-aortic balloon pump;
- Severe left ventricular dysfunction with a LV Ejection Fraction (LVEF) < 25% by echocardiography;
- Calcified pericardium;
- Septal hypertrophy;
- Primary Hypertrophic Obstructive Cardiomyopathy (HOCM);
- Active infection, endocarditis or pyrexia;
- Active peptic ulcer or Gastrointestinal (GI) bleeding within the past 3 months;
- Significant hepatic involvement (Child > B);
- Major lung disease (FEV < 0.8 or FEV1% < 30% of normal);
- Pulmonary hypertension;
- History of bleeding diathesis or coagulopathy;
- Hematologic disorder (WBC<3000mm3, Hb<9g/dL, platelet count <50000 cells/ mm3);
- Serum creatinine level greater than 3.0 mg/dL or chronic renal failure requiring dialysis;
- Neurological disease severely affecting ambulation or daily functioning, including dementia;
- Other procedure scheduled at the same time, whether surgery or percutaneous approach;
- Emergency procedure;
- Life expectancy < 12 months due to non-cardiac co-morbid conditions;
- Known hypersensitivity/contraindication to any study medication, contrast media, or nitinol;
- Currently participating in an investigational drug or another device study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Kerckhoff Klinik GmbH
Bad Nauheim, 61231
Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
Essen, 45122
Universitätsklinikum Freiburg Herz- und Gefäßchirurgie
Freiburg im Breisgau
Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefäßchirurgie
Hamburg, 20246
Herzzentrum Leipzig GmbH
Leipzig, 04289
About this study
Official title: Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Read the detailed description
A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.
- Conditions
- Aortic Stenosis Symptomatic
- Being tested
- ACURATE TA™
- Keywords
- Severe Symptomatic Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACURATE TA™Device
Also called ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery System
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| ACURATE TA™ | Experimental | Patients implanted with ACURATE TA™ Bioprosthesis Receives: Device: ACURATE TA™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety endpoint
Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE
Measured: 30 days
Secondary outcomes (5)
Performance endpoint
Stable ACURATE placement at intended site as assessed by angiography
Measured: Up to 24-hours post-procedure
Performance endpoint
Adequate ACURATE device function as assessed by echocardiography
Measured: Up to 24-hours post-procedure
Mortality
Freedom from Death at follow-up
Measured: 30 days, 60 days, 3 months, 6 months and 12 months
MAVRE at follow-up
Rate of MAVRE at follow-up
Measured: discharge or 7 days, 3 months, 6 months and 12 months
MACCE or Major Adverse Cardiac and Cerebrovascular Event
Rate of MACCE at follow up
Measured: 1 month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis SymptomaticStudies 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
- Model description
- Medical Device Study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich Mohr, Professor, Principal investigator, Herzzentrum Leipzig GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567278
- Sponsor's protocol ID
- 2009-01
- Other IDs
- DE/CA84/73-KL-30-09
- Acronym
- TA-FIM
- Status last verified
- May 2018
- First submitted
- 8 Dec 2014
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial on ACURATE™ Transapical Implantation in Patients With Severe Symptomatic Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03567278
- Acronym / sponsor ID
- TA-FIM / 2009-01
- Conditions
- Aortic Stenosis Symptomatic
- Keywords
- Severe Symptomatic Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 25 Jun 2018 (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.
Feasibility Trial on the ACURATE TA™ transapical implantation in patients presenting severe symptomatic aortic stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Detailed description
A single arm, prospective, multicenter, open trial up to 5 year follow-up with the SYMETIS ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high surgical risk for evaluating the feasibility and performance of the implantation and the safety at 30-Day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Medical Device Study
| Arm | Type | Receives |
|---|---|---|
| ACURATE TA™ | Experimental | Device: ACURATE TA™Patients implanted with ACURATE TA™ Bioprosthesis |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Patients older than 75 years;
- Additive EuroSCORE > 9 and/or STS > 9%;
- Severe symptomatic AS assessed by echocardiography, documented by a derived mean gradient > 40mmHg,and a native Aortic Valve Area (AVA) < 0.8 cm² or Aortic Valve Area Index (AVAI) < 0.6 cm²/m²;
- NYHA Functional Class > II;
- Aortic annulus (AAn) diameters between and including 21 mm up to 27 mm (21mm ≤ AAn ≤27mm) by transoesophageal echocardiography;
Key exclusion criteria (31 listed)
- Congenital unicuspid or bicuspid aortic valve;
- Severe eccentricity of calcification;
- Severe mitral regurgitation (> 2°);
- Pre-existing prosthetic heart valve in any position and /or prosthetic ring;
- Severe transapical access problem, non-reachable LV apex;
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 TA™Also: ACURATE TA™ Transapical Aortic Bioprosthesis and Delivery SystemACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery. | Device | ACURATE TA™ |
Primary outcome
Safety endpoint
Time frame: 30 days
Rate of Major Adverse Valve-Related Events (MAVRE) related to ACURATE
5 secondary outcomes
Performance endpoint
Time frame: Up to 24-hours post-procedure
Performance endpoint
Time frame: Up to 24-hours post-procedure
Mortality
Time frame: 30 days, 60 days, 3 months, 6 months and 12 months
MAVRE at follow-up
Time frame: discharge or 7 days, 3 months, 6 months and 12 months
MACCE or Major Adverse Cardiac and Cerebrovascular Event
Time frame: 1 month, 3 months, 6 months and 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 25 Jun 2018.
- 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.
Friedrich Mohr, Professor principal investigator
Herzzentrum Leipzig GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACURATE TA™ in people with Aortic Stenosis Symptomatic, run by Symetis SA at 5 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 7 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 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Safety endpoint (time frame: 30 days). 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 25 Jun 2018.