ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
Primary Purpose
Aortic Valve Stenosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAVR with CENTERA THV
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring THV, Transcatheter Heart Valve, CENTERA, self-expanding
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Cedars-Sinai Medical Center
- Stanford University Medical Center
- UC Health Northern Colorado (Medical Center of the Rockies)
- Washington Hospital Center
- Sarasota Memorial Hospital
- Emory University
- St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
- University of Kansas Health System
- Cardiovascular Research Institute of Kansas
- Brigham and Women's Hospital
- Henry Ford Hospital
- Washington University/ Barnes-Jewish Hospital
- Atlantic Health System Hospital Corp
- Columbia University Medical Center/ NYPH
- The Ohio Health Research Institute
- University of Pennsylvania
- Allegheny - Singer Research Institute
- Saint Thomas Health
- Baylor Heart and Vascular Hospital
- The University of Texas Health Science Center at Houston
- University of Texas Memorial Hermann
- The Heart Hospital Baylor Plano
- Baylor Scott and White, Central Texas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcatheter Aortic Valve Replacement (TAVR)
Arm Description
Outcomes
Primary Outcome Measures
All-cause Death
Number of participants that died
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03517436
Brief Title
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 18, 2018 (Actual)
Primary Completion Date
October 2, 2020 (Actual)
Study Completion Date
July 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
THV, Transcatheter Heart Valve, CENTERA, self-expanding
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcatheter Aortic Valve Replacement (TAVR)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TAVR with CENTERA THV
Intervention Description
TAVR with the Edwards CENTERA THV System
Primary Outcome Measure Information:
Title
All-cause Death
Description
Number of participants that died
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Leon, MD
Organizational Affiliation
Columbia University Medical Center/ NYPH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
UC Health Northern Colorado (Medical Center of the Rockies)
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St. Vincent Medical Group, Inc./St. Vincent Heart Center of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas Health System
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cardiovascular Research Institute of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University/ Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Atlantic Health System Hospital Corp
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Columbia University Medical Center/ NYPH
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny - Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Saint Thomas Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Baylor Scott and White, Central Texas
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
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