What side effects are associated with this type of intervention?

Transcatheter aortic valve replacement (TAVR) procedures, such as those involving the Edwards SAPIEN X4 valve, are associated with several potential side effects and complications. Common issues include vascular complications (e.g., bleeding or vessel damage), stroke, transient ischemic attacks, arrhythmias, and the need for a permanent pacemaker. Other potential complications include valve malpositioning, paravalvular leak, and infection. These side effects are typical of TAVR procedures and should be discussed with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

The FDA has approved several transcatheter heart valves for the treatment of aortic regurgitation, particularly in patients with failing aortic bioprosthetic valves. Notable approvals include the Edwards SAPIEN series, such as the SAPIEN 3 and SAPIEN XT, which are predecessors to the SAPIEN X4. These devices are used in transcatheter aortic valve replacement (TAVR) procedures, offering a less invasive alternative to open-heart surgery for high-risk patients. Other similar devices include the Medtronic CoreValve and Evolut series, which have also received FDA approval for similar indications.

What other types of research exist?

Promising alternatives to the Edwards SAPIEN X4 Transcatheter Heart Valve for aortic regurgitation patients include the Medtronic CoreValve Evolut PRO+ and the Boston Scientific ACURATE neo2. Both devices have shown effectiveness in transcatheter aortic valve replacement (TAVR) procedures and are being evaluated for their safety and efficacy in various clinical trials.

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Transcatheter Heart Valve

SAPIEN X4 THV for Failing Aortic Valves

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

Must not have

Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve

Subjects with planned concomitant ablation for atrial fibrillation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Summary

This trial tests a new artificial heart valve that can be inserted without open-heart surgery. It focuses on high-risk patients with failing aortic valves. The valve is placed using a thin tube, making the procedure safer for these patients. This new method offers a less invasive alternative to conventional surgery.

Who is the study for?

This trial is for adults with a failing aortic bioprosthetic valve who are at high surgical risk. They must have symptoms of heart dysfunction (NYHA class ≥ II) and be suitable for the SAPIEN X4 THV based on their valve size. Participants need to consent to study provisions. Exclusions include unstable valves, severe mitral issues, blood disorders, recent major cardiac events or procedures, pregnancy, certain anatomical features that complicate the procedure, active COVID-19 infection or related sequelae.

What is being tested?

The Edwards SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in patients with failing aortic bioprosthetic valves who face high risks from traditional surgery. The study will evaluate how well this new device works as an alternative to replace dysfunctional heart valves without open-heart surgery.

What are the potential side effects?

Potential side effects may include bleeding complications due to antithrombotic therapy required after implantation; risk of stroke; vascular complications from femoral sheath placement; irregular heartbeat requiring pacemaker insertion; infections like endocarditis; and potential damage to surrounding structures during implantation.

Eligibility Criteria

Exclusion Criteria

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

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My heart valve replacement doesn't work well, causing high blood pressure in my heart.

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I am scheduled for a procedure to treat atrial fibrillation.

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I refuse to receive blood transfusions.

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My body's structure allows safe placement of medical devices in my thigh.

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

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I have a surgical or transcatheter valve in my heart's mitral position.

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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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I am currently pregnant or breastfeeding.

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

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My heart valve leaks moderately or severely.

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

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I need a procedure to improve blood flow to my heart.

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I am scheduled for a surgery or catheter procedure within 30 days after the study starts.

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

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I have kidney problems or am on dialysis.

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I cannot take blood thinning medications due to my condition.

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

Kansas City Cardiomyopathy Questionnaire (KCCQ) score

New York Heart Association (NYHA) functional class

Trial Design

2Treatment groups

Experimental Treatment

Group I: Transcatheter Aortic Valve Replacement (TAVR) - THVExperimental Treatment1 Intervention

TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).

Group II: Transcatheter Aortic Valve Replacement (TAVR) - Surgical ValveExperimental Treatment1 Intervention

TAVR implant in subjects with a failing aortic surgical valve.

0 / 17Eligibility 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

The most common treatment for Aortic Regurgitation (AR), especially in patients with failing aortic bioprosthetic valves, is the transcatheter aortic valve replacement (TAVR) procedure. Devices like the Edwards SAPIEN X4 Transcatheter Heart Valve are used in this minimally invasive procedure. TAVR involves inserting a new valve within the failing bioprosthetic valve via a catheter, usually through the femoral artery. The new valve then takes over the function of the original valve, ensuring proper blood flow and reducing regurgitation. This treatment is crucial for AR patients as it restores normal valve function, alleviates symptoms, and significantly improves heart function and quality of life.

Current Key Issues in Transcatheter Aortic Valve Replacement Undergoing a Paradigm Shift.

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Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

182 Previous Clinical Trials

62,841 Total Patients Enrolled

Tamim M. Nazif, MDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

915 Total Patients Enrolled

Rahul P. Sharma, MBBSPrincipal InvestigatorStanford University

1 Previous Clinical Trials

915 Total Patients Enrolled

~117 spots leftby Dec 2025

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