ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
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
1 other identifier
interventional
101
1 country
23
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2018
CompletedFirst Posted
Study publicly available on registry
May 7, 2018
CompletedStudy Start
First participant enrolled
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 2, 2020
CompletedResults Posted
Study results publicly available
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
ExpectedNovember 13, 2025
October 1, 2025
2 years
April 25, 2018
September 2, 2021
October 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause Death
Number of participants that died
1 year
Study Arms (1)
Transcatheter Aortic Valve Replacement (TAVR)
EXPERIMENTALInterventions
TAVR with the Edwards CENTERA THV System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford University Medical Center
Stanford, California, 94305, United States
UC Health Northern Colorado (Medical Center of the Rockies)
Loveland, Colorado, 80538, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Emory University
Atlanta, Georgia, 30308, United States
St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
Indianapolis, Indiana, 46290, United States
University of Kansas Health System
Kansas City, Kansas, 66160, United States
Cardiovascular Research Institute of Kansas
Wichita, Kansas, 67226, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Washington University/ Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Atlantic Health System Hospital Corp
Morristown, New Jersey, 07960, United States
Columbia University Medical Center/ NYPH
New York, New York, 10032, United States
The Ohio Health Research Institute
Columbus, Ohio, 43214, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, 15212, United States
Saint Thomas Health
Nashville, Tennessee, 37205, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, 75226, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Texas Memorial Hermann
Houston, Texas, 77030, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Baylor Scott and White, Central Texas
Temple, Texas, 76508, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Research
- Organization
- Edwards Lifesciences
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Leon, MD
Columbia University Medical Center/ NYPH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2018
First Posted
May 7, 2018
Study Start
September 18, 2018
Primary Completion
October 2, 2020
Study Completion (Estimated)
July 1, 2030
Last Updated
November 13, 2025
Results First Posted
September 30, 2021
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share