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Transcatheter Heart Valve

TAVR for Heart Failure

N/A

Waitlist Available

Research Sponsored by Cardiovascular Research Foundation, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Heart Failure with NYHA class ≥ 2

Must not have

Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation)

Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether TAVR is safe and effective for heart failure patients with moderate aortic stenosis, as compared to those who receive no treatment.

Who is the study for?

This trial is for adults over 18 with advanced heart failure and moderate aortic valve stenosis, who've been on stable heart failure therapy for at least a month. They must have an ejection fraction under 50% but not below 20%, and can't be in critical condition or have severe other diseases.

What is being tested?

The study tests if using the SAPIEN 3 THV device to replace the aortic valve through the leg vein is safe and works better than just optimal heart failure therapy alone in improving patients' conditions.

What are the potential side effects?

Possible side effects include risks associated with heart valve replacement like bleeding, blood vessel complications, irregular heartbeat, stroke, infection risk from the procedure, and potential reactions to anesthesia or contrast media.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My heart condition limits my physical activities.

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My body is suitable for a specific heart valve replacement through my thigh.

Exclusion Criteria

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

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I am allergic or cannot take clopidogrel, aspirin, or blood thinners if needed.

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My doctor expects I have less than 2 years to live because of my cancer or other chronic illness.

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I was born with a one or two-leaf aortic valve.

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I have been advised to undergo surgery for a heart valve problem not involving the aorta.

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My heart's right ventricle is not working well.

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I have had a stroke that left me with some lasting disabilities.

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My kidney function is very low or I am on dialysis.

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My liver condition is severe (Child-Pugh C).

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I do not have an active infection, including heart infection.

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I am not willing to receive blood transfusions.

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I am not willing to undergo follow-up tests.

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I have severe leakage in my heart valves.

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I show signs of memory loss or confusion.

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My heart's pumping ability is very weak.

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I have severe lung disease or need daily oxygen support.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month 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

Change in KCCQ relative to baseline

Disabling Stroke

+1 more

Secondary study objectives

-All-cause death within EATI

MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of