What side effects are associated with this type of intervention?

Transcatheter aortic valve replacement (TAVR), including the Edwards SAPIEN X4 THV, is a common treatment for severe aortic stenosis. Known side effects of TAVR include vascular complications, bleeding, stroke, and arrhythmias. Other potential risks are valve leakage (paravalvular regurgitation), infection, and issues related to the positioning of the valve. While TAVR is generally less invasive than surgical valve replacement, it still carries significant risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has previously approved several transcatheter aortic valve replacement (TAVR) devices for the treatment of severe aortic stenosis. Notable among these are the Edwards SAPIEN valve series, including the SAPIEN, SAPIEN XT, and SAPIEN 3 valves. These devices are designed to improve blood flow by replacing the narrowed aortic valve without the need for open-heart surgery. Other approved TAVR devices include the Medtronic CoreValve and Evolut series. These minimally invasive treatments have been shown to be effective for patients who are at high or intermediate risk for surgical valve replacement.

What other types of research exist?

Promising alternatives to the Edwards SAPIEN X4 THV for aortic stenosis patients include the Medtronic CoreValve Evolut PRO+ and the Boston Scientific ACURATE neo2. Both devices have demonstrated safety and effectiveness in clinical trials and offer advanced features such as enhanced sealing to reduce paravalvular leak and improved delivery systems for precise placement.

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Transcatheter Heart Valve

SAPIEN X4 THV for Aortic Stenosis

N/A

Recruiting

Led By Tamim M. Nazif, 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

Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)

Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new heart valve that can be inserted without surgery in patients with severe heart valve narrowing. The new valve helps improve blood flow by replacing the damaged one through a minimally invasive procedure.

Who is the study for?

This trial is for individuals with severe, calcified aortic stenosis who are experiencing symptoms and have at least a moderate functional impairment due to the condition. They must understand the study and consent to participate. Exclusions include pregnancy, recent heart attacks or procedures, certain heart diseases, planned surgeries, extreme obesity (BMI > 50), very low life expectancy or ejection fraction, blood disorders, active infections including COVID-19.

What is being tested?

The SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in treating symptomatic severe calcific aortic stenosis. The study aims to see if this valve can improve heart function without major surgery by implanting it through a catheter.

What are the potential side effects?

Potential side effects may include risks associated with heart valve replacement such as bleeding complications, irregular heart rhythms, infection risk around the new valve area (endocarditis), stroke risk during implantation procedure 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:

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I have no surgeries or heart procedures planned within 30 days after the study, unless it's for treating coronary artery disease.

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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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I have a thickened heart muscle causing blockage below the valve.

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I am scheduled for a procedure to treat irregular heartbeat.

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My heart has a calcification risk that could complicate valve implantation.

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My heart disease cannot be treated with a stent.

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I am at high risk for blocked arteries after a heart valve implant.

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I currently have or had COVID-19 with lasting effects.

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I need a heart valve surgery within the next year.

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I have a condition that increases my risk of blood clots.

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

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

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I am currently pregnant or breastfeeding.

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I refuse to receive blood transfusions.

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My body allows for safe placement of medical devices in my thigh area.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Non-hierarchical composite of death and stroke

Secondary study objectives

Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline

New permanent pacemaker implantation

Paravalvular leak

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

Group I: TAVR - Main CohortExperimental Treatment1 Intervention

Subjects will undergo transcatheter aortic valve replacement (TAVR)

Group II: TAVR - Bicuspid RegistryExperimental Treatment1 Intervention

Subjects with bicuspid aortic valve morphology will undergo TAVR

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Aortic stenosis is commonly treated with transcatheter aortic valve replacement (TAVR), especially in patients who are at high risk for surgical aortic valve replacement (SAVR). TAVR involves the insertion of a new valve via a catheter, which is threaded through the blood vessels to the heart, where it replaces the narrowed aortic valve without the need for open-heart surgery. This procedure improves blood flow by ensuring the new valve opens and closes properly, reducing the heart's workload and alleviating symptoms such as shortness of breath and chest pain. The Edwards SAPIEN X4 THV, being studied for its safety and effectiveness, represents an advancement in TAVR technology, potentially offering better outcomes and fewer complications for patients with severe, symptomatic aortic stenosis.