Aortic Valve DiseaseCENTERA-1NCT01808274
Safety and Performance Study of the Edwards CENTERA 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 4 sites in 2 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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement. Read more about this study
- Who is it for?
- Ages 19 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
- 34 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Feb 2013to 23 Aug 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
- NYHA ≥ II.
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- 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
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Herzzentrum Universitaet Bonn
Bonn, 53127
Asklepios Klinik St Georg Hamburg
Hamburg, 20099
Heart Center Leipzig
Leipzig, 042 89
About this study
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Read the detailed description
This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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 |
|---|---|---|
| TAVR | Experimental | with CENTERA self-expanding valve 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
NAP
Measured: 30 days post-index procedure
Secondary outcomes (2)
device success
Device success is defined as a composite of the following events:
Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).
It is measured in % (favorable measures/total measures).
Measured: 30 days
device success
Device success is defined as a composite of the following events:
Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).
It is measured in % (favorable measures/total measures).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study start1 Feb 2013
- Primary completion17 Sep 2013
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 34 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. Mohr, MD, Principal investigator, Leipzig, Rhön Herzentrum (Germany)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808274
- Sponsor's protocol ID
- 2012-03
- Acronym
- CENTERA-1
- Status last verified
- Nov 2018
- First submitted
- 7 Mar 2013
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- ClinicalTrials.gov ID
- NCT01808274
- Acronym / sponsor ID
- CENTERA-1 / 2012-03
- Conditions
- Aortic Valve Disease
- Keywords
- Transcatheter Aortic Valve Replacement, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Collaborators
- Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
- Study start
- 1 Feb 2013 (actual)
- Primary completion
- 17 Sep 2013 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 11 Mar 2013 (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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Detailed description
This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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 |
|---|---|---|
| TAVR | Experimental | Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valvewith CENTERA self-expanding valve |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
- NYHA ≥ II.
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- 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 | TAVR |
Primary outcome
All-cause mortality rate
Time frame: 30 days post-index procedure
NAP
2 secondary outcomes
device success
Time frame: 30 days
device success
Time frame: 1 year
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 20 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Aortic Valve Disease
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. Windecker, MD principal investigator
Inselspital Bern (Switzerland)
Prof. Mohr, MD principal investigator
Leipzig, Rhön Herzentrum (Germany)
4 sites in 2 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 4 sites in 2 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. 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?
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 20 Nov 2018.