Symptomatic Aortic StenosisNCT03143686
ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
An observational study of Symptomatic Aortic Stenosis, run by Symetis SA at 17 sites in 4 countries.
Trial summary
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Symptomatic Aortic Stenosis
- What is being tested?
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 17 sitesin 4 countries
- Study dates
- Nov 2011to Nov 2013
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: ACURATE TA™ is approved for use to treat patients with severe aortic stenosis. The registry includes all comer patients following the Instructions For Use.
Who may be able to join
- Patient has severe aortic stenosis
- Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
- Patient willing to participate in the study and provides signed EC-approved informed consent
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Who cannot join
- Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
Germany14 sites
RWTH Aachen
Aachen, 52074
Zentralklinik Bad Berka
Bad Berka, 99437
Kerckhoff Klinik Bad Nauheim
Bad Nauheim, 61231
Herz-und Gefäss-Klinik GmbH
Bad Neustadt an der Saale, 97616
Schüchtermann-Schiller'sche Kliniken GmbH
Bad Rothenfelde, 49214
Uniklinik Köln Herzzentrum
Cologne, 50937
Herzzentrum Dresden Universitätsklinik
Dresden, 01307
Klinik für Tgorax und Gefässchirurgie
Essen, 45122
Universitäres Herzzentrum
Hamburg, 20251
Klinik für Herzchirurgie
Karlsruhe, 76185
Herzzentrum Leipzig
Leipzig, 04289
Universitäts Medizin Mainz
Mainz, 55131
Universitätsklinikum Regensburg
Regensburg, 93053
Sana Herzchirurgie Stuttgart GmbH
Stuttgart, 70174
About this study
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
Read the detailed description
A single arm, prospective, multicenter, non-randomized and open registry up to 1 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 surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.
- Conditions
- Symptomatic Aortic Stenosis
- Being tested
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Keywords
- Severe symptomatic Aortic Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACURATE TA™ Transapical Aortic BioprosthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ACURATE TA™ Transapical Aortic Bioprosthesis | The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted. Receives: Device: ACURATE TA™ Transapical Aortic Bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant .
MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.
Measured: 30 days and 12 Months Follow-up
Secondary outcomes (2)
Procedural Success post-implantation (up to 24 hours after device implantation)
Procedural success defined as successful ACURATE TA™ implantation at intended site and adequate device functioning immediately post-implantation and without intra-procedural mortality
Measured: Post-Implantation (up to 24 hours after device implantation)
Device success at 30 days and 12 Months follow-up
Device success at 30 day and 12 month follow-up visit defined as adequate functioning of the ACURATE TA™ as confirmed by echocardiography.
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 May 2017
- Study startNov 2011
- Primary completionDec 2012
- Study completionNov 2013
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 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
- NCT03143686
- Sponsor's protocol ID
- 2011-02
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2014
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
- ClinicalTrials.gov ID
- NCT03143686
- Acronym / sponsor ID
- 2011-02
- Conditions
- Symptomatic Aortic Stenosis
- Keywords
- Severe symptomatic Aortic Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (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.
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.
Detailed description
A single arm, prospective, multicenter, non-randomized and open registry up to 1 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 surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACURATE TA™ Transapical Aortic Bioprosthesis | – | Device: ACURATE TA™ Transapical Aortic BioprosthesisThe first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ACURATE TA™ is approved for use to treat patients with severe aortic stenosis. The registry includes all comer patients following the Instructions For Use.
Key inclusion criteria (4 listed)
- Patient has severe aortic stenosis
- Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
- Patient willing to participate in the study and provides signed EC-approved informed consent
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Key exclusion criteria (1 listed)
- Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.
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™ Transapical Aortic BioprosthesisAlso: 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. | Device | ACURATE TA™ Transapical Aortic Bioprosthesis |
Primary outcome
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant
Time frame: 30 days and 12 Months Follow-up
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant . MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.
2 secondary outcomes
Procedural Success post-implantation (up to 24 hours after device implantation)
Time frame: Post-Implantation (up to 24 hours after device implantation)
Device success at 30 days and 12 Months follow-up
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 19 Mar 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.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptomatic Aortic Stenosis, run by Symetis SA at 17 sites in 4 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 4 inclusion and 1 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 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Argentina, Italy, Switzerland. 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?
Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant (time frame: 30 days and 12 Months 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 19 Mar 2018.