Aortic Symptomatic StenosisTA-PILOTNCT03143673
ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2010-01)
A study testing ACURATE TA™ in people with Aortic Symptomatic Stenosis, run by Symetis SA at 5 sites in Germany.
Trial summary
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Symptomatic Stenosis
- 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
- 50 participants
- Where
- 5 sitesGermany
- Study dates
- Jan 2011to Jul 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 at least 75 years of age
- Additive EuroSCORE > 9
- Severe AS assessed by echocardiography and documented by a 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 (TEE)
- 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
Show all 30Show fewer
- 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 attack (TIA) or stroke in the last 3 months
- Untreated clinically significant coronary artery disease (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 (LVEF) < 30% by echocardiography
- Calcified pericardium
- Septal hypertrophy unacceptable for transapical procedure
- 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)
- Severe COPD requiring home oxygen
- History of bleeding diathesis or coagulopathy
- Hematologic disorder (WBC < 3000mm3, Hb < 9g/dL, platelet count < 50000 cells/ mm3)
- Chronic renal dysfunction with a serum creatinine level > 2.5 mg/dL or renal failure requiring dialysis
- Neurological disease severely affecting ambulation or daily functioning, including dementia
- Another surgical or percutaneous procedure scheduled at the same time
- 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 Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
Essen, 20246
Universitätsklinikum Essen Westdeutsches Herzzentrum Essen
Essen, 45122
Klinik für Herzchirurgie GmbH
Karlsruhe, 76185
Herzzentrum Leipzig GmbH
Leipzig, 04289
About this study
Official title: ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
The purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
Read the detailed description
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie 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 safety and performance of the implantation and safety at 30-D follow-up.
- Conditions
- Aortic Symptomatic Stenosis
- 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 | Patient 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.
Freedom from all-cause mortality at 30 day Follow Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Measured: 30-Day Follow-up
Freedom from all-cause mortality at 12 months Follow Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Measured: 12 months Follow-Up
Secondary outcomes (5)
Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;
2.1 Structural valve deterioration
2.2 Non-structural dysfunction of the implanted study device
2.3 Valve thrombosis, embolism, bleeding event
2.4 Operated valve endocarditis
2.5 Re-intervention on the implanted device
2.6 Valve-related mortality
2.7 Need for new permanent pacemaker or defibrillator within 14 days
Measured: 30-Days and at 12 Months Follow-up
Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.
Defined as cardiovascular death, myocardial infarction and stroke
Measured: 30-Day and 12-Month
Functional Improvement from baseline
per NYHA functional classification
Measured: 30-Days and 12-Month Follow-up
Procedural success
defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography as assessed at a Core Lab and without intraprocedural mortality.
Measured: 24 hours Post-Procedure
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab. The following datapoints will be analyzed:
6.1 Effective orifice area and index (EOA/EOAI)
6.2 Transvalvular Gradients (Peak and mean)
6.3 Paravalvular and intravalvular (Central) leaks
6.4 Aortic Insufficiency
6.5 LV function and hemodynamics
6.6 Valve function and morphology
Measured: 30-Day and 12-Month 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 May 2017
- Study startJan 2011
- Primary completionJul 2011
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Symptomatic 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Walther, Professor, Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143673
- Sponsor's protocol ID
- 2010-01
- Other IDs
- 95.02-5660-6278
- Acronym
- TA-PILOT
- Status last verified
- Jul 2023
- First submitted
- 8 Dec 2014
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE™ Transapical Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
- ClinicalTrials.gov ID
- NCT03143673
- Acronym / sponsor ID
- TA-PILOT / 2010-01
- Conditions
- Aortic Symptomatic Stenosis
- Keywords
- Severe Symptomatic Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 May 2017 (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 purpose of this study is to evaluate safety of the study device and study device performance in patients presenting with severe aortic stenosis who are considered to be high risk for open surgical repair.
Detailed description
A single arm, prospective, multicenter, non-randomized, and open trial, up to 5 years follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation vie 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 safety and performance of the implantation and safety at 30-D follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACURATE TA™ | Experimental | Device: ACURATE TA™Patient 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 (6 listed)
- Patients at least 75 years of age
- Additive EuroSCORE > 9
- Severe AS assessed by echocardiography and documented by a 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 (TEE)
Key exclusion criteria (30 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
Freedom from all-cause mortality at 30 day Follow Up
Time frame: 30-Day Follow-up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 30 days post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
Freedom from all-cause mortality at 12 months Follow Up
Time frame: 12 months Follow-Up
The primary study objective is to evaluate the safety of the ACURATE™ Transapical Aortic Bioprosthesis at 12 months post-procedure in patients presenting with severe aortic valve stenosis at high risk for conventional AVR surgery.
5 secondary outcomes
Rate of Major Adverse Valve-Related Events (MAVRE) at 30 days and at 12 month follow up related to the study device as defined as;
Time frame: 30-Days and at 12 Months Follow-up
Rate of Major Adverse Cardiac and Cerebrovascular-Related Events (MACCE) at 30 days and at 12 Month and defined as cardiovascular death, myocardial infarction and stroke.
Time frame: 30-Day and 12-Month
Functional Improvement from baseline
Time frame: 30-Days and 12-Month Follow-up
Procedural success
Time frame: 24 hours Post-Procedure
Device success at 30 Days and 12 Month follow-up as defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography as assessed at a CoreLab.
Time frame: 30-Day and 12-Month 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 27 Jul 2023.
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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.
Thomas Walther, Professor principal investigator
Kerckhoff Klinik
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 Symptomatic Stenosis, 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 6 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 27 Jul 2023. 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?
Freedom from all-cause mortality at 30 day Follow Up (time frame: 30-Day Follow-up). 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 27 Jul 2023.