TAVR with CENTERA THV for Aortic Stenosis
Recruiting at 22 trial locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Edwards Lifesciences
No Placebo Group
Trial Summary
What is the purpose of this trial?
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).
Research Team
ML
Martin Leon, MD
Principal Investigator
Columbia University Medical Center/ NYPH
Eligibility Criteria
This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for surgery. Participants must have symptoms and be in NYHA functional class ≥ II. They cannot join if they have certain heart conditions, recent heart attacks or strokes, severe lung disease, kidney failure, bleeding disorders, or an allergy to Nitinol.Inclusion Criteria
You have heart failure that affects your ability to do daily activities.
My heart team considers me at intermediate risk for open heart surgery.
The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
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Exclusion Criteria
I have not had a serious heart infection in the last 6 months.
The medical team has assessed that you are very weak and may not be able to handle the treatment.
My aortic valve is either one-flap, two-flap, or not hardened by calcium.
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Treatment Details
Interventions
- CENTERA THV (Transcatheter Aortic Valve Replacement (TAVR))
Trial OverviewThe study tests the Edwards CENTERA Transcatheter Heart Valve System's safety and performance in those with symptomatic aortic stenosis deemed intermediate risk for surgical replacement. It involves replacing the diseased valve through a less invasive procedure than open-heart surgery.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton
Edwards Lifesciences
Chief Medical Officer since 2023
MD from Stanford University
Bernard Zovighian
Edwards Lifesciences
Chief Executive Officer since 2023
MBA from INSEAD