Aortic StenosisNCT03454360
CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System
An observational study of Aortic Stenosis, run by Symetis SA at 10 sites in Germany.
Trial summary
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- ACURATE neo™ Aortic Bioprosthesis
- Type of treatment
- Medical device
- How many people
- 107 participants
- Where
- 10 sitesGermany
- Study dates
- 6 Feb 2018to 30 Apr 2020
- 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: All subjects with severe aortic stenosis, for whom the transapical access is the most suitable approach as per heart-team consensus, who signed the Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC), and are deemed to be candidates to undergo transcatheter aortic valve implantation with the ACURATE neo™ Aortic Bioprosthesis and its Transapical Delivery System as per clinical practice at each participating site
Who may be able to join
- Symptomatic patients with severe aortic stenosis;
- Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;
Who cannot join
- Patients unable or unwilling to give inform consent;
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Kerckhoff Klinik
Bad Nauheim, 61231
Herz-und Gefäß-Kilink GmbH
Bad Neustadt an der Saale, 97616
Krankenhausbetriebgesellschaft
Bad Oeynhausen, D-32545
BG Klinik Bergmannsheil
Bochum, 44789
Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie
Frankfurt, 60590
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Freiburg im Breisgau, 79106
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Herzzentrum Leipzig
Leipzig, 04289
Deutsches Herzzentrum München
München, 80636
Universitätsklinikum Regensburg
Regensburg, 93053
About this study
Official title: Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.
Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.
Read the detailed description
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.
- Conditions
- Aortic Stenosis
- Being tested
- ACURATE neo™ Aortic Bioprosthesis
- Keywords
- TAVI, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve, 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 neo™ Aortic BioprosthesisDevice
Also called ACURATE neo™ TA Delivery System
TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
the rate of all-cause mortality as measured at 30-days
Measured: 30 days
Secondary outcomes (7)
Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
Clinical events as defined per VARC 2 consensus document at procedure:
All cause mortality; Stroke; Myocardial Infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications
Measured: Procedure to Discharge, 30 days and 12-months
Procedural Success
Defined as absence of intra-procedure mortality (procedure to 24H) AND absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one implanted aortic bioprosthesis (valve-in-valve or ectopic deployment) or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication. The procedure can be considered as success despite the presence of residual aortic regurgitation, which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.
Measured: Procedure to 24-hours
Device Success
Defined as;
- Absence of intra-procedure mortality (procedure to 24H) AND,
- Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,
- Intended performance of the prosthetic heart valve assessed prior to discharge per local standard of care and defined as:
- No prosthesis-patient mismatch (EAOi >0.85 cm2/m2 or EAOi >0.7 cm2/m2 for BMI ≥30 kg/m2) ) AND,
- Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND,
- No moderate or severe prosthetic valve regurgitation.
For echo parameters for the performance assessment, a pre-discharge echo examination should be performed as per local standard of care. If echo parameter pre-discharge is missing, any echo parameter within 45 days post-procedure may be used.
Measured: Post-procedure to Discharge.
VARC 2 Composite Safety
Defined as:
- All-cause mortality
- All stroke
- Life-threatening bleeding
- Acute Kidney Injury- Stage 2 or 3
- Coronary Artery Obstruction requiring intervention
- Major Vascular Complications
- Valve-related dysfunction requiring repeat procedure
Measured: 30-days
Functional improvement as per NYHA Functional Classification
Change on NYHA Class between baseline and different follow-up
Measured: from baseline to, discharge, 30-days and 12-months follow-up.
Improvement of EOA and mean Trans-prosthetic gradient
If the echo parameter pre-discharge is missing to assess the intended performance, any echo parameter data within 45-days post procedure may be used for the missing values;
Measured: from baseline to discharge, 30- days and 12 months follow-up
Total Aortic Regurgitation
Change on Aortic Regurgitation over time at follow-up
Measured: post-procedure, prior to discharge, at 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 posted5 Mar 2018
- Study start6 Feb 2018
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Why it stopped: Sponsor business decision unrelated to product safety or efficacy.
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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Symetis SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hilker, Prof.Dr.med, Principal investigator, Universitätsklinikum Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454360
- Sponsor's protocol ID
- 2016-03
- Status last verified
- Dec 2020
- First submitted
- 31 Jul 2017
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
- ClinicalTrials.gov ID
- NCT03454360
- Acronym / sponsor ID
- 2016-03
- Conditions
- Aortic Stenosis
- Keywords
- TAVI, Transcatheter Aortic Valve Replacement, Transcatheter Aortic Valve, Transapical Access
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor business decision unrelated to product safety or efficacy.
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Symetis SAIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 5 Mar 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.
The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.
Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.
Detailed description
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All subjects with severe aortic stenosis, for whom the transapical access is the most suitable approach as per heart-team consensus, who signed the Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC), and are deemed to be candidates to undergo transcatheter aortic valve implantation with the ACURATE neo™ Aortic Bioprosthesis and its Transapical Delivery System as per clinical practice at each participating site
Key inclusion criteria (2 listed)
- Symptomatic patients with severe aortic stenosis;
- Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;
Key exclusion criteria (1 listed)
- Patients unable or unwilling to give inform consent;
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 neo™ Aortic BioprosthesisAlso: ACURATE neo™ TA Delivery SystemTAVI; Transcatheter Aortic Valve Replacement. Transapical Access. | Device | – |
Primary outcome
All cause mortality
Time frame: 30 days
the rate of all-cause mortality as measured at 30-days
7 secondary outcomes
Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.
Time frame: Procedure to Discharge, 30 days and 12-months
Procedural Success
Time frame: Procedure to 24-hours
Device Success
Time frame: Post-procedure to Discharge.
VARC 2 Composite Safety
Time frame: 30-days
Functional improvement as per NYHA Functional Classification
Time frame: from baseline to, discharge, 30-days and 12-months follow-up.
Improvement of EOA and mean Trans-prosthetic gradient
Time frame: from baseline to discharge, 30- days and 12 months follow-up
Total Aortic Regurgitation
Time frame: post-procedure, prior to discharge, at 30-days and 12-months follow-up;
Results and safety
The study was stopped early (reason given: Sponsor business decision unrelated to product safety or efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: Undecided. The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).
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Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
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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.
Michael Hilker, Prof.Dr.med principal investigator
Universitätsklinikum Regensburg
10 sites in 1 country: 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 10 sites in Germany.
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 2 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: stopped early, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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 was stopped early (reason given: Sponsor business decision unrelated to product safety or efficacy.). Results are not available in the source record.
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?
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 11 Dec 2020.