Aortic Stenosis > SAPIEN X4 THV

SAPIEN X4 THV for Aortic Stenosis

Recruiting in Palo Alto (17 mi)

+68 other locations

Overseen By Tamim M. Nazif, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Edwards Lifesciences

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I have severe, calcified aortic stenosis.

The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Your aortic valve size is suitable for the SAPIEN X4 THV.

Exclusion Criteria

I have not had a heart attack in the last 30 days.

I have severe leaking or significant narrowing of my mitral heart valve.

I cannot take blood thinning medications due to my condition.

Participant Groups

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.

Group I: TAVR - Main Cohort Experimental Treatment 1 Intervention

Subjects will undergo transcatheter aortic valve replacement (TAVR)

Group II: TAVR - Bicuspid Registry Experimental Treatment 1 Intervention

Subjects with bicuspid aortic valve morphology will undergo TAVR

SAPIEN X4 THV is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as SAPIEN X4 THV for:

• Severe aortic stenosis in patients at high risk for surgical complications
• Failing aortic bioprosthetic valves

🇪🇺 Approved in European Union as SAPIEN X4 THV for:

• Severe aortic stenosis in patients at high risk for surgical complications
• Failing aortic bioprosthetic valves

🇨🇦 Approved in Canada as SAPIEN X4 THV for:

• Severe aortic stenosis in patients at high risk for surgical complications
• Failing aortic bioprosthetic valves

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Columbia University Medical Center New York, NY

Carolinas Health System Charlotte, NC

Alexian Brothers Hospital Network Elk Grove Village, IL

Methodist Le Bonheur Healthcare Germantown, TN

More Trial Locations

Who Is Running the Clinical Trial?

Edwards Lifesciences Lead Sponsor

References