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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: TAVR with CENTERA THV

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Loveland, Colorado, United States, 80538
      • UC Health Northern Colorado (Medical Center of the Rockies)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Health System
    • Wichita, Kansas, United States, 67226
      • Cardiovascular Research Institute of Kansas
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University/ Barnes-Jewish Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Atlantic Health System Hospital Corp
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/ NYPH
  • Ohio
    • Columbus, Ohio, United States, 43214
      • The Ohio Health Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny - Singer Research Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Saint Thomas Health
  • Texas
    • Dallas, Texas, United States, 75226
      • Baylor Heart and Vascular Hospital
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77030
      • University of Texas Memorial Hermann
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
    • Temple, Texas, United States, 76508
      • Baylor Scott and White, Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Severe, calcific AS
2. NYHA functional class ≥ II
3. Judged by the Heart Team to be at intermediate risk for open surgical therapy
4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

1. Native aortic annulus size unsuitable for sizes 23, 26 or 29 mm CENTERA THV based on 3D imaging analysis
2. Aortic valve is unicuspid, bicuspid or non-calcified
3. Pre-existing mechanical or bioprosthetic valve in any position
4. Known hypersensitivity to Nitinol (nickel or titanium)
5. Severe aortic regurgitation (> 3+)
6. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis
7. Ventricular dysfunction with left ventricular ejection fraction < 30%
8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
9. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure
10. Subjects with planned concomitant ablation for atrial fibrillation
11. Hypertrophic cardiomyopathy with obstruction
12. Coronary anatomy that increases the risk of coronary artery obstruction post-TAVR
13. Complex coronary artery disease
14. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
15. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
16. Active bacterial endocarditis within 180 days of the valve implant procedure
17. Stroke or transient ischemic attack within 90 days of the valve implant procedure
18. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of the valve implant procedure
19. Severe lung disease or currently on home oxygen
20. Severe pulmonary hypertension
21. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the valve implant procedure
22. History of cirrhosis or any active liver disease
23. Renal insufficiency and/or renal replacement therapy at the time of screening
24. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
25. Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
26. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
27. Significant frailty as determined by the Heart Team
28. Immobility that would prevent completion of study procedures
29. Subject refuses blood products
30. Body mass index > 50 kg/m2
31. Estimated life expectancy < 24 months
32. Positive urine or serum pregnancy test in female subjects of childbearing potential
33. Currently participating in an investigational drug or another device study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR)	Device: TAVR with CENTERA THV; TAVR with the Edwards CENTERA THV System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Death	Number of participants that died	1 year

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Martin Leon, MD, Columbia University Medical Center/ NYPH

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2018
• Primary Completion (Actual): October 2, 2020
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): May 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: THV; Transcatheter Heart Valve; CENTERA; self-expanding
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2017-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes