Aortic Stenosis Symptomatic2011-03NCT03752996
ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis (2011-03)
A study testing ACURATE TF™ Aortic Valve System in people with Aortic Stenosis Symptomatic, run by Symetis SA at 5 sites in 2 countries.
Trial summary
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe 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 TF™ Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 9 May 2012to 30 Mar 2022
- 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 < 1.0 cm2
- New York Heart Association (NYHA) Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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
- Trans-esophageal echocardiogram (TEE) is contraindicated
- Left Ventricle 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 Transient 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 Obstruction 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
5 sites in 2 countries.
5 sites in 2 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
Official title: ACURATE TF™ Transfemoral Aortic Bioprosthesis for Implantation in Patients With Severe Aortic Stenosis
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe 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, non-randomized, open trial, up to 5 Years follow-up 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.
- Conditions
- Aortic Stenosis Symptomatic
- Being tested
- ACURATE TF™ Aortic Valve System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACURATE TF™ Aortic Valve SystemDevice
Transcatheter Aortic Valve Implantation
| Study group | Role | What they receive |
|---|---|---|
| ACURATE TF™ Aortic Valve System | Experimental | ACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement . Receives: Device: ACURATE TF™ Aortic Valve System |
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-Days
Secondary outcomes (1)
Rate of MACCE (major cardiac and cerebrovascular event)
Rate of major cardiac and cerebrovascular event (MACCE) defined as cardiovascular death, myocardial infarction and stroke
Measured: 30-Days 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 posted26 Nov 2018
- Study start9 May 2012
- Primary completion30 Jun 2017
- Study completion30 Mar 2022
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
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Won Keun Kim, Dr. Med., Principal investigator, Kerckhoff Klinik Bad Nauheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752996
- Sponsor's protocol ID
- 2011-03
- Acronym
- 2011-03
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2018
- Last updated
- 23 Feb 2023
- 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 23 Feb 2023. 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
- ClinicalTrials.gov ID
- NCT03752996
- Acronym / sponsor ID
- 2011-03 / 2011-03
- Conditions
- Aortic Stenosis Symptomatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 9 May 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 26 Nov 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.
First-In-Man Study on the ACURATE TF™ Transfemoral Aortic Bioprosthesis Implantation in Patients with Severe Aortic Stenosis to collect human feasibility data pertaining to the safety and performance of the device.
Detailed description
A single arm, prospective, multicenter, non-randomized, open trial, up to 5 Years follow-up 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACURATE TF™ Aortic Valve System | Experimental | Device: ACURATE TF™ Aortic Valve SystemACURATE TF™ Aortic Valve System is intended for subjects with severe symptomatic Aortic Stenosis and considered high risk for surgical conventional Aortic Valve Replacement . |
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 < 1.0 cm2
- New York Heart Association (NYHA) Functional Class > II
- Aortic annulus diameter from ≥ 21mm up to ≤ 27mm measured by 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™ Aortic Valve SystemTranscatheter Aortic Valve Implantation | Device | ACURATE TF™ Aortic Valve System |
Primary outcome
Freedom from all-cause mortality
Time frame: 30-Days
Rate of all-cause mortality
1 secondary outcome
Rate of MACCE (major cardiac and cerebrovascular event)
Time frame: 30-Days 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 23 Feb 2023.
- 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.
Won Keun Kim, Dr. Med. principal investigator
Kerckhoff Klinik Bad Nauheim, Germany
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACURATE TF™ Aortic Valve System in people with Aortic Stenosis Symptomatic, run by Symetis SA at 5 sites in 2 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 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 5 sites in Germany, Brazil. 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-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 23 Feb 2023.