Aortic Valve DiseaseNCT02458560
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
A study testing Edwards CENTERA Self-Expanding Transcatheter Heart Valve in people with Aortic Valve Disease, run by Edwards Lifesciences at 27 sites in 9 countries.
Trial summary
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 27 sitesin 9 countries
- Study dates
- Mar 2015to 13 Aug 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
- High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
- NYHA ≥ II.
- Study patient is an adult of legal consent age.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Who cannot join
- Acute myocardial infarction ≤ 30 days before the intended treatment.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- Mixed aortic valve disease (with predominant aortic regurgitation).
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
Germany11 sites
Klinikum Augsburg
Augsburg, 86156
Segeberger Kliniken GmbH
Bad Segeberg, 23795
Charité - Universitaetsmedizin Berlin
Berlin, 10117
Herzzentrum Universitaet Bonn
Bonn, 53105
Asklepios Klinik St Georg
Hamburg, 20099
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246
Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
Karlsruhe, 76133
Herzzentrum Leipzig GmbH
Leipzig, 04289
Deutsches Herzzentrum Muenchen
Munich, 80636
LMU - Klinikum der Universitaet Muenchen
Munich, 81377
Universitaetsklinikum Muenster
Münster, 48149
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Prince Charles Hospital
Brisbane, Queensland, 4032
Epworth Healthcare
Melbourne, Victoria, 3121
France3 sites
Institut Hospitalier Jacques Cartier
Massy, 91300
CHU Pontchaillou
Rennes, 35033
Clinique Pasteur
Toulouse, 31300
Italy3 sites
Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
Catania, 95124
Ospedale San Raffaele s.r.l.
Milan, 20132
Azienda Ospedaliero-Universitaria Pisana
Pisa, 56124
Netherlands3 sites
Academisch Medisch Centrum (AMC)
Amsterdam, 1105
Erasmus University Medical Center Rotterdam
Rotterdam, 3015
Universitair Medical Center (UMC) Utrecht
Utrecht, 3584
About this study
Official title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
Read the detailed description
This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.
- Conditions
- Aortic Valve Disease
- Being tested
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Medical subject headings
- Aortic Valve Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards CENTERA Self-Expanding Transcatheter Heart ValveDevice
Also called TAVR, TAVI
The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Not described Receives: Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate
Measured: 30 days post-index procedure
Secondary outcomes (1)
Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.
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 posted1 Jun 2015 (estimated)
- Study startMar 2015
- Primary completion22 Aug 2016
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Prof. Windecker, MD, Principal investigator, Inselspital Bern (Switzerland)Prof. Hermann Reichenspurner, MD, Principal investigator, University Heart Center Hamburg (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02458560
- Sponsor's protocol ID
- 2014-03
- Status last verified
- Oct 2021
- First submitted
- 28 May 2015
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.
PubMed 30947942Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.
PubMed 29268926
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
- ClinicalTrials.gov ID
- NCT02458560
- Acronym / sponsor ID
- 2014-03
- Conditions
- Aortic Valve Disease
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
- Study start
- Mar 2015 (actual)
- Primary completion
- 22 Aug 2016 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 1 Jun 2015 (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.
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
Detailed description
This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
- High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
- NYHA ≥ II.
- Study patient is an adult of legal consent age.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Key exclusion criteria (4 listed)
- Acute myocardial infarction ≤ 30 days before the intended treatment.
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- Mixed aortic valve disease (with predominant aortic regurgitation).
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 |
|---|---|---|
| Edwards CENTERA Self-Expanding Transcatheter Heart ValveAlso: TAVR, TAVIThe Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR). | Device | single-arm |
Primary outcome
All-cause mortality rate
Time frame: 30 days post-index procedure
1 secondary outcome
Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.
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 18 Oct 2021.
- Derived from this study: PubMed 30947942Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.
- Derived from this study: PubMed 29268926Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.
- 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.
Prof. Windecker, MD principal investigator
Inselspital Bern (Switzerland)
Prof. Hermann Reichenspurner, MD principal investigator
University Heart Center Hamburg (Germany)
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards CENTERA Self-Expanding Transcatheter Heart Valve in people with Aortic Valve Disease, run by Edwards Lifesciences at 27 sites in 9 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 5 inclusion and 4 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 18 Oct 2021. 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, Australia, France, Italy, Netherlands and 4 more countries. 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?
All-cause mortality rate (time frame: 30 days post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02458560, which also lists 2 linked publications.
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 18 Oct 2021.