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Transcatheter Valve Replacement

SAPIEN 3 Ultra System for Aortic Stenosis

N/A
Waitlist Available
Led By John Webb, 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 aortic stenosis meeting specific transthoracic echocardiogram criteria
New York Heart Association functional class ≥ II
Must not have
Severe pulmonary hypertension
Renal insufficiency and/or renal replacement therapy at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge, expected to be within 1-5 days post-procedure]
Awards & highlights
No Placebo-Only Group

Summary

This trial will show how safe and effective the SAPIEN 3 Ultra System is for people with severe aortic valve disease who are at an intermediate risk for standard aortic valve replacement.

Who is the study for?
This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for open heart surgery. They must understand the study and consent to participate, have specific heart function classifications (NYHA class ≥ II), and meet certain echocardiogram criteria. Exclusions include complex coronary disease, intolerance to antithrombotic therapy, pregnancy in women of childbearing potential, participation in other studies, certain heart conditions like hypertrophic cardiomyopathy or valve issues, severe ventricular dysfunction or regurgitation problems.
What is being tested?
The SAPIEN 3 Ultra System is being tested for safety and performance in replacing the aortic valve using a less invasive method than open-heart surgery. This system includes both the delivery mechanism and the actual replacement valve designed specifically for people with narrowed valves due to calcium buildup.
What are the potential side effects?
While not explicitly listed here, side effects may include risks associated with catheter-based procedures such as bleeding at the access site, infection risk from implanted devices or materials used during implantation procedure; possible damage to blood vessels; irregular heartbeats; stroke; kidney damage from contrast dye used during imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart valve is severely narrowed and has calcium deposits.
Select...
I have moderate to severe heart condition symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe high blood pressure in the lungs.
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I have kidney problems or am on dialysis.
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I have a history of blood disorders or abnormal bleeding.
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I have severe leaking or moderate blockage in my heart's mitral valve.
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My heart's structure increases the risk of artery blockage after a valve replacement.
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I have a thickened heart muscle that obstructs blood flow.
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I do not have major aortic disease that would make surgery unsafe.
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I have severe lung disease or need home oxygen.
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My blood vessels in the hip area are not suitable for safe medical device insertion.
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My heart's pumping ability is significantly reduced.
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I haven't needed help with my breathing or heart function in the last 30 days.
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I am scheduled for a procedure to treat irregular heartbeat.
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I refuse to receive blood products.
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I cannot take blood thinning medication during or after my valve surgery.
Select...
My heart condition involves complex artery issues that can't be fully treated with surgery.
Select...
My aortic valve is either one-flap, two-flap, or not hardened by calcium.
Select...
I had a heart attack less than 30 days before my planned valve surgery.
Select...
I have a history of cirrhosis or another liver disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge, expected to be within 1-5 days post-procedure]
This trial's timeline: 3 weeks for screening, Varies for treatment, and discharge, expected to be within 1-5 days post-procedure] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Procedural Success
Secondary study objectives
Major Vascular Complications
Valve Migration or Embolization

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
63,008 Total Patients Enrolled
60 Trials studying Aortic Valve Stenosis
32,491 Patients Enrolled for Aortic Valve Stenosis
John Webb, MDPrincipal InvestigatorSt. Paul's Hospital
5 Previous Clinical Trials
1,527 Total Patients Enrolled
2 Trials studying Aortic Valve Stenosis
199 Patients Enrolled for Aortic Valve Stenosis
Bernard Prendergast, ProfPrincipal InvestigatorSt. Thomas Hospital

Media Library

SAPIEN 3 Ultra System (Transcatheter Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT03471065 — N/A
Aortic Valve Stenosis Research Study Groups: Transcatheter Aortic Valve Replacement (TAVR)
Aortic Valve Stenosis Clinical Trial 2023: SAPIEN 3 Ultra System Highlights & Side Effects. Trial Name: NCT03471065 — N/A
SAPIEN 3 Ultra System (Transcatheter Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03471065 — N/A
~13 spots leftby Nov 2025
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