ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis

Running, not enrolling · Not applicable

Conditions studied: Aortic Valve Stenosis

In brief

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).

Key facts

Study ID

NCT03517436

Run by

Edwards Lifesciences

People needed

101

Starts

2018-09-18

Expected to finish

2030-07-01

Last updated by the study team

2025-11-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University Medical Center — Stanford, California, United States
• UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Emory University — Atlanta, Georgia, United States
• St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC — Indianapolis, Indiana, United States
• University of Kansas Health System — Kansas City, Kansas, United States
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Washington University/ Barnes-Jewish Hospital — St Louis, Missouri, United States
• Atlantic Health System Hospital Corp — Morristown, New Jersey, United States
• Columbia University Medical Center/ NYPH — New York, New York, United States
• The Ohio Health Research Institute — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny - Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Saint Thomas Health — Nashville, Tennessee, United States
• Baylor Heart and Vascular Hospital — Dallas, Texas, United States
• The University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Texas Memorial Hermann — Houston, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• Baylor Scott and White, Central Texas — Temple, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.