Aortic Valve StenosisNCT03517436
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
A study testing TAVR with CENTERA THV in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 23 sites in United States.
Trial summary
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- TAVR with CENTERA THV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 23 sitesUnited States
- Study dates
- 18 Sep 2018to Jul 2030
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Severe, calcific AS
- NYHA functional class ≥ II
- Judged by the Heart Team to be at intermediate risk for open surgical therapy
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
- Known hypersensitivity to Nitinol (nickel or titanium)
- Severe aortic regurgitation (> 3+)
- Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
Show all 33Show fewer
- Ventricular dysfunction with left ventricular ejection fraction < 30%
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
- Subjects with planned concomitant ablation for atrial fibrillation
- Hypertrophic cardiomyopathy with obstruction
- Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
- Complex coronary artery disease
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- Active bacterial endocarditis within 180 days of the valve implant procedure
- Stroke or transient ischemic attack within 90 days of the valve implant procedure
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
- Severe lung disease or currently on home oxygen
- Severe pulmonary hypertension
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
- History of cirrhosis or any active liver disease
- Renal insufficiency and/or renal replacement therapy at the time of screening
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
- Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Significant frailty as determined by the Heart Team
- Immobility that would prevent completion of study procedures
- Subject refuses blood products
- Body mass index > 50 kg/m2
- Estimated life expectancy < 24 months
- Positive urine or serum pregnancy test in female subjects of childbearing potential
- Currently participating in an investigational drug or another device study
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory University
Atlanta, Georgia, 30308
Brigham and Women's Hospital
Boston, Massachusetts, 02115
The Ohio Health Research Institute
Columbus, Ohio, 43214
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226
Henry Ford Hospital
Detroit, Michigan, 48202
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Texas Memorial Hermann
Houston, Texas, 77030
St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, 46290
University of Kansas Health System
Kansas City, Kansas, 66160
Cedars-Sinai Medical Center
Los Angeles, California, 90048
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, 80538
Atlantic Health System Hospital Corp
Morristown, New Jersey, 07960
Saint Thomas Health
Nashville, Tennessee, 37205
Columbia University Medical Center/ NYPH
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, 15212
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
Baylor Scott and White, Central Texas
Temple, Texas, 76508
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226
About this study
Official title: A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Read the detailed description
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
- Conditions
- Aortic Valve Stenosis
- Being tested
- TAVR with CENTERA THV
- Keywords
- THV, Transcatheter Heart Valve, CENTERA, self-expanding
- 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.
TAVR with CENTERA THVDevice
TAVR with the Edwards CENTERA THV System
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Not described Receives: Device: TAVR with CENTERA THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Death
Number of participants that died
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 posted7 May 2018
- Study start18 Sep 2018
- Primary completion2 Oct 2020
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Leon, MD, Principal investigator, Columbia University Medical Center/ NYPH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517436
- Sponsor's protocol ID
- 2017-18
- Status last verified
- Oct 2025
- First submitted
- 25 Apr 2018
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Controlled, Multicenter Study to Establish the Safety and Effectiveness of the CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03517436
- Acronym / sponsor ID
- 2017-18
- Conditions
- Aortic Valve Stenosis
- Keywords
- THV, Transcatheter Heart Valve, CENTERA, self-expanding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- Jul 2030 (estimated)
- First posted
- 7 May 2018 (actual)
- Results
- Posted 30 Sep 2021
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 the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for surgical aortic valve replacement (SAVR).
Detailed description
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | Device: TAVR with CENTERA THV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Severe, calcific AS
- NYHA functional class ≥ II
- Judged by the Heart Team to be at intermediate risk for open surgical therapy
- The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (33 listed)
- Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
- Aortic valve is unicuspid, bicuspid or non-calcified
- Pre-existing mechanical or bioprosthetic valve in any position
- Known hypersensitivity to Nitinol (nickel or titanium)
- Severe aortic regurgitation (> 3+)
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 |
|---|---|---|
| TAVR with CENTERA THVTAVR with the Edwards CENTERA THV System | Device | Transcatheter Aortic Valve Replacement (TAVR) |
Primary outcome
All-cause Death
Time frame: 1 year
Number of participants that died
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Martin Leon, MD principal investigator
Columbia University Medical Center/ NYPH
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVR with CENTERA THV in people with Aortic Valve Stenosis, run by Edwards Lifesciences at 23 sites in United States.
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 4 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. 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?
Yes. Results are posted in the registry (first posted 30 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Death (time frame: 1 year). 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 13 Nov 2025.