ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: TAVR with CENTERA THV
- Registration Number
- NCT03517436
- Lead Sponsor
- Edwards Lifesciences
- 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).
- Detailed Description
A prospective, single-arm, controlled, multicenter study. Up to 2 roll-ins were allowed per site but not counted towards total enrollment.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 101
- 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.
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcatheter Aortic Valve Replacement (TAVR) TAVR with CENTERA THV -
- Primary Outcome Measures
Name Time Method All-cause Death 1 year Number of participants that died
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
Emory University
🇺🇸Atlanta, Georgia, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
UC Health Northern Colorado (Medical Center of the Rockies)
🇺🇸Loveland, Colorado, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Columbia University Medical Center/ NYPH
🇺🇸New York, New York, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Atlantic Health System Hospital Corp
🇺🇸Morristown, New Jersey, United States
Washington University/ Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
The Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
University of Texas Memorial Hermann
🇺🇸Houston, Texas, United States
Allegheny - Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Baylor Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Baylor Scott and White, Central Texas
🇺🇸Temple, Texas, United States