Aortic Valve StenosisNCT03699345
CENTERA PMCF: Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System
An observational study of Aortic Valve Stenosis, run by Edwards Lifesciences at 11 sites in 6 countries.
Trial summary
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Transcatheter Aortic Valve Replacement (TAVR)
- Type of treatment
- Medical device
- How many people
- 87 participants
- Where
- 11 sitesin 6 countries
- Study dates
- 7 Jan 2019to 20 Aug 2024
- 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: Adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Who may be able to join
- Severe native valve calcific aortic stenosis
- Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).
Who cannot join
- Known hypersensitivity to Nitinol (nickel or titanium)
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- Inability to tolerate anticoagulation/antiplatelet therapy
Trial locations and contacts
11 sites in 6 countries.
11 sites in 6 countries
United Kingdom4 sites
Royal Victoria Hospital Belfast
Belfast, BT12 6BA
Queen Elisabeth Hospital Birmingham
Birmingham, B15 2TH
Brighton and Sussex University Hospital
Brighton, East Sussex, BN2 5BE
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Germany2 sites
Johannes Gutenberg Universitaet Mainz
Mainz, 55131
Deutsches Herzzentrum Muenchen (DHM)
München, 80636
Spain2 sites
Vall d'Hebron University Hospital - Barcelona
Barcelona, 08035
Hospital Universitario Central de Asturias
Oviedo, 33011
About this study
Official title: Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Read the detailed description
A prospective, international, single arm, multi-center post market clinical follow-up study.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Transcatheter Aortic Valve Replacement (TAVR)
- Keywords
- CENTERA, THV, Transcatheter Heart Valve
- 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.
Transcatheter Aortic Valve Replacement (TAVR)Device
TAVR with the Edwards CENTERA THV System and accessories
| Study group | Role | What they receive |
|---|---|---|
| Edwards CENTERA THV | Not described Receives: Device: Transcatheter Aortic Valve Replacement (TAVR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
All-cause mortality at 30 days
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 posted9 Oct 2018
- Study start7 Jan 2019
- Primary completion14 Aug 2019
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Hermann Reichenspurner, Principal investigator, UKE Hamburg-Eppendorf - University Heart CenterProf.Dr. Stephan Windecker, Principal investigator, Inselspital, Klinik für Kardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699345
- Sponsor's protocol ID
- 2017-07
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Study to Monitor Device Performance and Outcomes of the CENTERA Transcatheter Heart Valve System
- ClinicalTrials.gov ID
- NCT03699345
- Acronym / sponsor ID
- 2017-07
- Conditions
- Aortic Valve Stenosis
- Keywords
- CENTERA, THV, Transcatheter Heart Valve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 9 Oct 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.
This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Detailed description
A prospective, international, single arm, multi-center post market clinical follow-up study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edwards CENTERA THV | – | Device: Transcatheter Aortic Valve Replacement (TAVR) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Key inclusion criteria (2 listed)
- Severe native valve calcific aortic stenosis
- Judged by the Heart Team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator).
Key exclusion criteria (3 listed)
- Known hypersensitivity to Nitinol (nickel or titanium)
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- Inability to tolerate anticoagulation/antiplatelet therapy
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 |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR)TAVR with the Edwards CENTERA THV System and accessories | Device | Edwards CENTERA THV |
Primary outcome
All-Cause Mortality
Time frame: 30 days
All-cause mortality at 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 4 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
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. Hermann Reichenspurner principal investigator
UKE Hamburg-Eppendorf - University Heart Center
Prof.Dr. Stephan Windecker principal investigator
Inselspital, Klinik für Kardiologie
11 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Edwards Lifesciences at 11 sites in 6 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 2 inclusion and 3 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 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, Germany, Spain, Denmark, France and 1 more country. 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 (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 4 Nov 2024.