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Transcatheter Aortic Valve Replacement (TAVR)

TAVR with CENTERA THV for Aortic Stenosis

N/A
Waitlist Available
Led By Martin Leon, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe, calcific AS
Must not have
Active bacterial endocarditis within 180 days of the valve implant procedure
Inability to tolerate or condition precluding treatment with antithrombotic therapy during or after the valve implant procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with severe aortic valve stenosis who are at intermediate risk for surgical aortic valve replacement (SAVR).

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects may include risks associated with catheter-based procedures such as blood vessel complications, bleeding, irregular heartbeats, stroke, infection around the valve implant site and possible need for permanent pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe, calcified aortic stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had a serious heart infection in the last 6 months.
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I cannot take blood thinning medication during or after my valve surgery.
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My heart's pumping ability is significantly reduced.
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I have a thickened heart muscle that obstructs blood flow.
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My aortic valve is either one-flap, two-flap, or not hardened by calcium.
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My blood vessels in the hip area are not suitable for safe medical device insertion.
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I have severe lung disease or need home oxygen.
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I have severe high blood pressure in the lungs.
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I haven't needed heart or lung support machines in the last 30 days.
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My heart valve size does not fit the 23, 26, or 29 mm valve sizes.
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I have severe leaking or moderate blockage in my heart's mitral valve.
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I refuse to receive blood transfusions.
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I had a heart attack less than 30 days before my planned valve surgery.
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I am scheduled for a procedure to treat irregular heartbeat.
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I have not had a stroke or mini-stroke in the last 90 days.
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I have a history of blood disorders or abnormal bleeding.
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I can move enough to complete study tasks.
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My heart's structure increases the risk of artery blockage after a valve replacement.
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I have complex heart artery disease.
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I do not have major aortic disease that would make surgery unsafe.
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I have a history of cirrhosis or currently have liver disease.
Select...
I have kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause Death

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
63,007 Total Patients Enrolled
60 Trials studying Aortic Valve Stenosis
32,490 Patients Enrolled for Aortic Valve Stenosis
Martin Leon, MDPrincipal InvestigatorColumbia University Medical Center/ NYPH
3 Previous Clinical Trials
2,256 Total Patients Enrolled

Media Library

CENTERA THV (Transcatheter Aortic Valve Replacement (TAVR)) Clinical Trial Eligibility Overview. Trial Name: NCT03517436 — N/A
Aortic Valve Stenosis Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis Clinical Trial 2023: CENTERA THV Highlights & Side Effects. Trial Name: NCT03517436 — N/A
CENTERA THV (Transcatheter Aortic Valve Replacement (TAVR)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03517436 — N/A
~14 spots leftby Nov 2025
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