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Transcatheter Heart Valve

TAVR for Aortic Stenosis (EARLY TAVR Trial)

N/A
Waitlist Available
Led By Philippe Généreux, 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 aortic stenosis
Patient is asymptomatic
Must not have
Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
Patient is symptomatic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve to standard clinical surveillance in patients with severe, calcific aortic stenosis who are not experiencing symptoms.

Who is the study for?
This trial is for people aged 65 or older with severe, calcific aortic stenosis who show no symptoms and have an ejection fraction of at least 50%. Participants must be able to give informed consent and have an STS risk score ≤10. It's not for those with symptomatic heart conditions, other diseases requiring surgery, certain valve anomalies, recent heart attacks or strokes, bleeding disorders, severe lung disease or infections like COVID-19.
What is being tested?
The study compares the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) implantation against regular clinical surveillance in patients without symptoms but diagnosed with severe aortic stenosis. The goal is to assess if early intervention with THV improves outcomes compared to just monitoring the condition.
What are the potential side effects?
While specific side effects are not listed here, procedures involving transcatheter heart valves can include risks such as bleeding, blood vessel complications, irregular heart rhythms (arrhythmias), stroke, infection and potential need for a permanent pacemaker.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with severe narrowing of the aortic valve.
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I do not have any symptoms.
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My heart surgery risk score is 10 or less.
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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't needed heart or lung support machines in the last 30 days.
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I am experiencing symptoms.
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I need heart valve surgery due to my heart condition.
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My aortic valve is abnormal and not suitable for a specific heart valve procedure.
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I have severe leaking or significant narrowing of my mitral heart valve.
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I cannot take blood thinning medications due to my condition.
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My heart has a calcification that could risk complications after a valve replacement.
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I have severe lung disease or need home oxygen.
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I do not have major aortic disease that would make surgery unsafe.
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I refuse to receive blood products.
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I am allergic to iodine-based contrast and cannot be treated with pre-medication.
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I currently have or had COVID-19 with lasting effects.
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I have kidney problems or am on dialysis.
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I have a blood disorder affecting my white cells, red cells, or platelets.
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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 a history of cirrhosis or another active liver disease.
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I have severe high blood pressure in the lungs.
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I have a thickened heart muscle that obstructs blood flow.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years 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, all stroke, and unplanned cardiovascular hospitalization
Secondary study objectives
Change in Left Ventricular Ejection Fraction (LVEF)
Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points
Death or disabling stroke
+2 more

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TAVRExperimental Treatment1 Intervention
Transcatheter aortic valve replacement (TAVR)
Group II: CSActive Control1 Intervention
Clinical surveillance (CS)

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,207 Total Patients Enrolled
Philippe Généreux, MDPrincipal InvestigatorGagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
4 Previous Clinical Trials
4,728 Total Patients Enrolled

Media Library

Edwards SAPIEN 3 / SAPIEN 3 Ultra THV (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT03042104 — N/A
Aortic Stenosis Research Study Groups: CS, TAVR
Aortic Stenosis Clinical Trial 2023: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV Highlights & Side Effects. Trial Name: NCT03042104 — N/A
Edwards SAPIEN 3 / SAPIEN 3 Ultra THV (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03042104 — N/A
~108 spots leftby Nov 2025
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