Aortic StenosisTA-SAVI2NCT02663375
ACURATE TA™ Valve Implantation Registry: SAVI 2
An observational study of Aortic Stenosis, run by Symetis SA at 27 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 collect continued surveillance data pertaining to safety and performance of the device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 27 sitesin 4 countries
- Study dates
- Nov 2013to Jan 2016
- How long will I take part?
- 1 Year
- 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 inclusion criteria are broad in order to allow the device to be used in an all-comers population and 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
27 sites in 4 countries.
27 sites in 4 countries
Germany23 sites
Klinikum Augsburg
Augsburg, 86156
Zentralklinik Bad Berka GmbH
Bad Berka, 99437
Herz- und Gefäßzentrum Bad Bevensen
Bad Bevensen, 29459
Kerckhoff-Klinik
Bad Nauheim, 61231
Herz- und Gefäßklinik GmbH
Bad Neustadt an der Saale, 97616
Herz- und Diabeteszentrum NRW ,Bad Oeynhausen Klinik für Thorax- und Kardiovaskularchirurgie
Bad Oeynhausen, 32545
Deutsches Herzzentrum Berlin
Berlin, 13353
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, 16321
Klinikum der Ruhr-Universität Bochum Klinik für Herz-und Thoraxchirurgie
Bochum, 44801
Herzzentrum Universitätsklinikum Köln
Cologne, 50937
Sana-Herzzentrum Cottbus GmbH
Cottbus, 03048
Technische Universität Dresden
Dresden, 01062
Klinik für Kardiologie und Thorax-Kardiovaskuläre_Westdeutsches Herzzentrum Essen
Essen, 45122
Justus-Liebig-Universität Gießen
Giessen, 35392
Klinik für Thorax-, Herz- und Gefäßchirurgie Georg-August-Universität
Göttingen, 37075
Universitätsklinikum Hamburg-Eppendorf Klinik für Herz-und Gefässchirurgie
Hamburg, 20246
Klinik für Herzchirurgie Karlsruhe GmbH
Karlsruhe, 76185
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum München des Freistaates Bayern
München, 80636
Klinikum Nürnberg Süd
Nuremberg, 90471
Universitätsklinikum Regensburg Klinik und Poliklinik für Herz-, Thorax- und herznahe Gefäßchirurgie
Regensburg, 93053
SHG-Kliniken Völklingen Klinik für Herz-, Thorax- und Gefäßchirurgie
Völklingen, 66333
Universitätsklinikum Würzburg Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie
Würzburg, 97080
Switzerland2 sites
Inselspital-Stiftung, Universitätsklinik für Herz- und Gefässchirurgie
Bern, 3010
Universität Zürich, Universitätsklinik für Herz- und Gefässchirurgie, Universitätsspital
Zurich, 8091
Austria1 site
Wiener Krankensanstaltenverbund Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, 1130
Italy1 site
U.O.C. cardiochirurgia per adulti- Stabilimento di Massa
Massa, 56126
About this study
Official title: Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
Read the detailed description
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.
The ACURATE TA™ 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 surgery is considered to be associated with high surgical risk.
The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.
- Conditions
- Aortic Stenosis
- Being tested
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Keywords
- TAVI, Aortic Stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transapical Access
- Medical subject headings
- Aortic Valve 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 Biorposthesis | Patients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System 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 all-cause mortality at 30 days follow-up
Rate of all-cause mortality at 30 days follow-up
Measured: 30-Day Follow-up
Secondary outcomes (4)
Rate of clinical endpoints (VARC II) at 30 days and 12 months
Rate of clinical endpoints (VARC II) at 30 days and 12 months:
- Mortality
- Stroke
- Myocardial infarction
- Bleeding complication
- Acute kidney injury
- Vascular complication
- Conduction disturbances and arrhythmia
- Other TAVI-related complications
Measured: 30-Days and 12 Months Follow-up
Procedural success post-implant
Procedural success post-implant defined as ACURATE TA™ implanted in intended location with the following criteria:
- Insufficiency < +3
- Mean aortic gradient < 20 mmHg
- EOA ≥ 1.0 cm2
- No valve-in-valve or conversion to surgery performed
Measured: Procedure to 24h Post-implantation
Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up
Device success analyzed by ECHO measurement at 7 days or discharge (whichever occurs first) and at 12 months follow-up and defined as the following criteria:
- ACURATE TA™ implanted in intended location
- No impingement of the mitral valve
- Normal coronary blood flow
- Valve-in-valve insufficiency < +3
- Mean gradient < 20mmHg
- EOA ≥ 1.0 cm2
- No valve-in-valve or conversion to surgery performed
Measured: 7-Days Follow-up and 12-Months Follow-up
Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months
Functional improvement from baseline as per NYHA Functional Classification at 30 days and at 12 months follow-up.
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 posted26 Jan 2016 (estimated)
- Study startNov 2013
- Primary completionJan 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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)
- Target duration
- 1 Year
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
- NCT02663375
- Sponsor's protocol ID
- 2013-04
- Acronym
- TA-SAVI2
- 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
- Symetis ACURATE TA™ Valve Implantation Using TransApical Access:SAVI2 Registry
- ClinicalTrials.gov ID
- NCT02663375
- Acronym / sponsor ID
- TA-SAVI2 / 2013-04
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Aortic Stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transapical Access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Jan 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.
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
Detailed description
The SAVI2 registry is a single arm, prospective, multicenter, non-randomized and open registry up to 1 year follow-up with the Symetis ACURATE TA™.
The ACURATE TA™ 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 surgery is considered to be associated with high surgical risk.
The primary objectives of the registry is to further evaluate the safety and performance of the implantation and the safety at 30-Day Follow-up.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACURATE TA™ Transapical Aortic Biorposthesis | – | Device: ACURATE TA™ Transapical Aortic BioprosthesisPatients implanted with ACURATE TA™ Transapical Aortic Biorposthesis and Delivery System |
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 inclusion criteria are broad in order to allow the device to be used in an all-comers population and 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 Biorposthesis |
Primary outcome
Rate of all-cause mortality at 30 days follow-up
Time frame: 30-Day Follow-up
Rate of all-cause mortality at 30 days follow-up
4 secondary outcomes
Rate of clinical endpoints (VARC II) at 30 days and 12 months
Time frame: 30-Days and 12 Months Follow-up
Procedural success post-implant
Time frame: Procedure to 24h Post-implantation
Device success at 7 Day or Discharge (which ever comes first) and at 12 months follow-up
Time frame: 7-Days Follow-up and 12-Months Follow-up
Functional improvement from baseline as per NYHA Functional Classification at 30 days and 12 months
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 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.
Thomas Walther, Professor principal investigator
Kerckhoff Klinik
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Symetis SA at 27 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 27 sites in Germany, Switzerland, Austria, Italy. 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 all-cause mortality at 30 days follow-up (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 19 Mar 2018.