Symptomatic Aortic StenosisNCT03003650
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort
A study testing ACURATE TF™ in people with Symptomatic Aortic Stenosis, run by Symetis SA at 6 sites in 3 countries.
Trial summary
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- ACURATE TF™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2011to Aug 2017
- 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 75 years of age and older
- Logistic EuroSCORE ≥ 20%
- Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2
- New York Heart Association (NYHA) Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
- Patient not a surgical candidate due to significant co-morbid conditions unrelated to aortic stenosis
- Patient willing to participate in the study and provide signed informed consent
Who cannot join
- Unicuspid or bicuspid aortic valve
- Extreme eccentricity of calcification
- Severe mitral regurgitation ( >2+)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- Aortic or peripheral anatomy NOT appropriate for transfemoral implant
- Thoracic (TAA) or abdominal (AAA) aortic aneurysm
Show all 27Show fewer
- Presence of endovascular stent graft for treatment of TAA or AAA
- TEE is contraindicated
- Left Ventricular Ejection Fraction (LVEF) < 30% by echocardiography (ECHO)
- ECHO evidence of intracardiac mass, thrombus, or vegetation
- Acute Myocardial Infarction (AMI) within 1 month prior to implant procedure
- Percutaneous Coronary Intervention (PCI), except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
- Previous Transien Ischemic Attack (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
- History of bleeding diathesis or coagulopathy or refusal of blood transfusions
- Systolic pressure <80 mmHg, cardiogenic shock, need for inotropic support or Intra-Aortic Balloon Pump (IABP)
- Primary hypertrophic obstructive cardiomyopathy (HOCM)
- Active infection, endocarditis or pyrexia
- Hepatic failure
- Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
- Refusal of surgery
- Severe Chronic Obstructive Pulmonary Disease (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
- Known hypersensitivity/contraindication to study medication, contrast media, or nitinol
- Currently participating in an investigational drug or another device study
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Germany4 sites
Kerckhoff Klinik GmbH
Bad Nauheim, 61231
Universitätsklinikum Bonn
Bonn, 53105
Herzzentrum Universitätsklinikum Köln
Cologne, 50937
Universitäres Herzzentrum Hamburg
Hamburg, 20246
About this study
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts
Read the detailed description
A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year Follow-up.
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- ACURATE TF™
- 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 TF™Device
Also called ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery System
ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .
| Study group | Role | What they receive |
|---|---|---|
| Symetis ACURATE TF™ | Experimental | Patient implanted with ACURATE TF™Bioprosthesis. Receives: Device: ACURATE TF™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from all-cause mortality
Rate of all-cause mortality
Measured: 30-Day Follow-up
Secondary outcomes (4)
Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months follow-up related to ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System and defined as all cause death, myocardial infarction, re-intervention and stroke.
Measured: 30-Days and 12 Months Follow-up
Change in NYHA class over time
Functional improvement from baseline NYHA classification at 30 day and at 12 month follow-up.
Measured: 30-Day and 12-Month
Procedural success during device implantation
Procedural Success defined as stable study device placement at intended site and adequate device functioning immediately post-implantation, confirmed by angiography and echocardiography and without intra-procedural mortality.
Measured: intraoperative
Device success
Device success is defined as adequate functioning of the study device as confirmed by angiography and/or echocardiography.
The following data points will be analyzed for adequate functioning of the study device:
- Effective orifice area and index (EOA)
- Peak jet velocity
- Transvalvular aortic gradient (mean)
- Paravalvular and intravalvular (central) leak
- Aortic Insufficiency
- 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 posted28 Dec 2016 (estimated)
- Study startSep 2011
- Primary completionJul 2013
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003650
- Sponsor's protocol ID
- TF89
- Status last verified
- Nov 2018
- First submitted
- 2 Dec 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis:CE-approval Cohort
- ClinicalTrials.gov ID
- NCT03003650
- Acronym / sponsor ID
- TF89
- Conditions
- Symptomatic Aortic Stenosis
- Keywords
- Severe Symptomatic Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 28 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.
First clinical experience on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human data pertaining to the safety and performance of the device from three different cohorts
Detailed description
A prospective, multicenter, "CE-approval cohort" analysis with the Symetis ACURATE TF™ Transfemoral Aortic Bioprosthesis for minimal invasive implantation via transfemoral access to treat patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open heart surgery is considered to be associated with high risk, to evaluate the feasibility and performance of the implantation at 30-Days and at 1-Year 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 |
|---|---|---|
| Symetis ACURATE TF™ | Experimental | Device: ACURATE TF™Patient implanted with ACURATE TF™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 75 years of age and older
- Logistic EuroSCORE ≥ 20%
- Severe aortic stenosis characterized by mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or aortic valve area of < 1.0 cm2
- New York Heart Association (NYHA) Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by Trans-esophageal Echocardiography (TEE)
Key exclusion criteria (27 listed)
- Unicuspid or bicuspid aortic valve
- Extreme eccentricity of calcification
- Severe mitral regurgitation ( >2+)
- Pre-existing prosthetic heart valve in any position and / or prosthetic ring
- Aortic or peripheral anatomy NOT appropriate for transfemoral implant
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 TF™Also: ACURATE TF™Transfemoral Aortic Bioprosthesis and Delivery SystemACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement . | Device | Symetis ACURATE TF™ |
Primary outcome
Freedom from all-cause mortality
Time frame: 30-Day Follow-up
Rate of all-cause mortality
4 secondary outcomes
Rate of MACCE (major cardiac and cerebrovascular event) related to the ACURATE TF™ Transfemoral Aortic Bioprosthesis and Delivery System.
Time frame: 30-Days and 12 Months Follow-up
Change in NYHA class over time
Time frame: 30-Day and 12-Month
Procedural success during device implantation
Time frame: intraoperative
Device success
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 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACURATE TF™ in people with Symptomatic Aortic Stenosis, run by Symetis SA at 6 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 7 inclusion and 27 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 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, Brazil, Japan. 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 (time frame: 30-Day Follow-up). 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 Nov 2018.