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
Brief Summary
To establish the safety and effectiveness 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. Additional subjects may be enrolled in a bicuspid registry.
Study Type
Interventional
Primary Outcome
Non-hierarchical composite endpoint of all-cause death and/or stroke
Condition
Aortic Valve Stenosis
Intervention
TAVR with CENTERA THV
Study Arms / Comparison Groups
Transcatheter Aortic Valve Replacement (TAVR)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
142
Start Date
September 18, 2018
Completion Date
July 2030
Primary Completion Date
October 2, 2020
Eligibility Criteria
Inclusion Criteria: 1. Severe, calcific AS meeting the following transthoracic echocardiogram (TTE) criteria: - AV area ≤ 1.0 cm2 OR AV area index ≤ 0.6 cm2/m2 - Jet velocity ≥ 4.0 m/s OR mean gradient ≥ 40 mmHg 2. NYHA functional class ≥ II 3. Judged by the Heart Team to be at intermediate risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 3% and < 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the risk calculator) 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: 1. Pre-existing mechanical or bioprosthetic valve in any position. (Of note, mitral ring is not an exclusion). 2. Known hypersensitivity to Nitinol (nickel or titanium) 3. Severe aortic regurgitation (> 3+) 4. Severe mitral regurgitation (> 3+) or ≥ moderate stenosis 5. Evidence of an acute myocardial infarction ≤ 30 days before the valve implant procedure 6. Stroke or transient ischemic attack within 90 days of the valve implant procedure 7. Severe lung disease or currently on home oxygen 8. Severe pulmonary hypertension 9. History of cirrhosis or any active liver disease
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Martin Leon, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03517436
Organization ID
2017-18
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Martin Leon, MD, Principal Investigator, Columbia University Medical Center/ NYPH
Verification Date
October 2020