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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 belowSelect...
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:Select...
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.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreAwards & 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
62,116 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with severe narrowing of the aortic valve.You have a serious problem with a heart valve called the aortic valve.I haven't needed heart or lung support machines in the last 30 days.You have a pre-existing mechanical or bioprosthetic heart valve.Your doctor thinks you have less than 2 years to live.I have not had a stroke or mini-stroke in the last 3 months.I have not had a serious heart infection in the last 6 months.I am experiencing symptoms.You have evidence of a mass or blood clot inside your heart based on a heart imaging test.I do not have any symptoms.Your body mass index (BMI) is over 50, which means you are very overweight.My heart surgery risk score is 10 or less.I need heart valve surgery due to my heart condition.My aortic valve is abnormal and not suitable for a specific heart valve procedure.I have severe leaking or significant narrowing of my mitral heart valve.I cannot take blood thinning medications due to my condition.My heart has a calcification that could risk complications after a valve replacement.I am 65 years old or older.I have severe lung disease or need home oxygen.I do not have major aortic disease that would make surgery unsafe.I refuse to receive blood products.I am allergic to iodine-based contrast and cannot be treated with pre-medication.I currently have or had COVID-19 with lasting effects.Your aortic valve size is not suitable for the available replacement options.I have kidney problems or am on dialysis.I have a blood disorder affecting my white cells, red cells, or platelets.My blood vessels in the hip area are not suitable for safe medical device insertion.I have had symptoms or treatment for narrowed neck arteries within the last month.I had a heart attack less than 30 days ago.The medical team thinks you are very weak.Your heart is pumping blood normally.I have a history of cirrhosis or another active liver disease.I have severe high blood pressure in the lungs.I have a thickened heart muscle that obstructs blood flow.
Research Study Groups:
This trial has the following groups:- Group 1: CS
- Group 2: TAVR
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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