← Back to Search

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

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.Check my eligibility

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.See study design

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

Select...

I have severe, calcified aortic stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had a serious heart infection in the last 6 months.

Select...

I cannot take blood thinning medication during or after my valve surgery.

Select...

My heart's pumping ability is significantly reduced.

Select...

I have a thickened heart muscle that obstructs blood flow.

Select...

My aortic valve is either one-flap, two-flap, or not hardened by calcium.

Select...

My blood vessels in the hip area are not suitable for safe medical device insertion.

Select...

I have severe lung disease or need home oxygen.

Select...

I have severe high blood pressure in the lungs.

Select...

I haven't needed heart or lung support machines in the last 30 days.

Select...

My heart valve size does not fit the 23, 26, or 29 mm valve sizes.

Select...

I have severe leaking or moderate blockage in my heart's mitral valve.

Select...

I refuse to receive blood transfusions.

Select...

I had a heart attack less than 30 days before my planned valve surgery.

Select...

I am scheduled for a procedure to treat irregular heartbeat.

Select...

I have not had a stroke or mini-stroke in the last 90 days.

Select...

I have a history of blood disorders or abnormal bleeding.

Select...

I can move enough to complete study tasks.

Select...

My heart's structure increases the risk of artery blockage after a valve replacement.

Select...

I have complex heart artery disease.

Select...

I do not have major aortic disease that would make surgery unsafe.

Select...

I have a history of cirrhosis or currently have liver disease.

Select...

I have kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

All-cause Death

Trial Design

1Treatment groups

Experimental Treatment

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

0 / 23Eligibility criteria met

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

62,320 Total Patients Enrolled

61 Trials studying Aortic Valve Stenosis

32,640 Patients Enrolled for Aortic Valve Stenosis

Martin Leon, MDPrincipal InvestigatorColumbia University Medical Center/ NYPH

3 Previous Clinical Trials

2,356 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

~15 spots leftby Jul 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.