Aortic StenosisSAVI TFNCT02306226
Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
An observational study of Aortic Stenosis, run by Symetis SA.
Trial summary
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Aortic Stenosis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Apr 2017
- How long will I take part?
- 12 Months
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: As the ACURATE neo™ 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 is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
- Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Who cannot join
- 1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
About this study
Official title: Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device
Read the detailed description
The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System.
The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.
The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device.
The secondary objective is to evaluate adverse events and device performance of the newly marketed device.
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Aortic stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transfemoral access
- Medical subject headings
- Aortic Valve Stenosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2016
- Study completionApr 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helge Möllmann, Prof., Principal investigator, Kerckhoff Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306226
- Sponsor's protocol ID
- 2013-05
- Acronym
- SAVI TF
- Status last verified
- Mar 2018
- First submitted
- 2 Sep 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 Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
- ClinicalTrials.gov ID
- NCT02306226
- Acronym / sponsor ID
- SAVI TF / 2013-05
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Aortic stenosis, Transcatheter aortic valve replacement, Transcatheter aortic valve implantation, Transfemoral access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 3 Dec 2014 (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 aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device
Detailed description
The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System.
The ACURATE neo™ and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.
The primary objective is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device.
The secondary objective is to evaluate adverse events and device performance of the newly marketed device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- As the ACURATE neo™ 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 (3 listed)
- Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
- Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Key exclusion criteria (1 listed)
- 1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral 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.
Primary outcome
Rate of all-cause mortality
Time frame: 30 days
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.
Helge Möllmann, Prof. principal investigator
Kerckhoff Klinik
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, run by Symetis SA.
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 3 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.
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 (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 19 Mar 2018.