What side effects are associated with this type of intervention?

Transcatheter heart valve implantation, such as the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA systems, is a common treatment for congenital heart defects involving dysfunctional valves or conduits. Known side effects of this procedure include bleeding, vascular complications, arrhythmias, stroke, and infection. Additionally, there is a risk of valve malfunction or migration, which may necessitate further interventions. Patients may also experience complications related to anesthesia and contrast agents used during the procedure.

What prior FDA approvals exist?

The FDA has approved several transcatheter heart valve systems for the treatment of congenital heart defects, particularly for patients with dysfunctional valves or conduits. Notably, the Edwards SAPIEN 3 and SAPIEN XT valves have been approved for transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis who are at high or extreme risk for open-heart surgery. These devices are designed to replace dysfunctional valves or conduits without the need for more invasive surgical procedures, offering a less invasive option for patients with congenital heart defects.

What other types of research exist?

Promising alternatives to the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve for congenital heart defect patients include the Medtronic Melody Transcatheter Pulmonary Valve and the Abbott Portico Transcatheter Aortic Valve System. Both have demonstrated efficacy and safety in clinical trials and are designed for minimally invasive valve replacement procedures.

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Transcatheter Heart Valve

SAPIEN 3 Valve for Pulmonary Valve Dysfunction

N/A

Recruiting

Led By D. Scott Lim, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

Weight ≥ 20 kg (44 lbs.)

Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use

Must not have

Inappropriate anatomy for femoral introduction and delivery of the study valve

Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a special heart valve that can be inserted without open-heart surgery. It targets patients with faulty heart valves in the pulmonic position. The new valve is delivered through a tube and helps the heart pump blood properly. The Direct Flow Medical valve has been developed with several important revisions to improve the efficacy and safety of the procedure.

Who is the study for?

This trial is for individuals weighing at least 44 lbs with a dysfunctional heart valve or conduit in the pulmonic position, requiring intervention and having specific measurements. Participants must not have active infections, blood disorders, recent procedures, or severe non-cardiac diseases affecting life expectancy. Pregnant women and those with certain allergies are excluded.

What is being tested?

The study tests the safety and effectiveness of Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems in patients needing pulmonary valve replacement due to dysfunction. It aims to improve heart function by replacing the faulty valve without open-heart surgery.

What are the potential side effects?

Potential side effects may include bleeding complications, irregular heart rhythms, infection risks associated with implantation procedures, allergic reactions to materials used in valves or medications during procedure, and possible damage to nearby heart structures.

Eligibility Criteria

Inclusion Criteria

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

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I weigh at least 44 pounds.

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I need a procedure for my heart valve and the area where it will be placed fits the required size.

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My heart valve condition is moderate or severe, or my heart has a specific high pressure.

Exclusion Criteria

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

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My body's structure doesn't allow for the study valve to be inserted through my thigh.

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I need a procedure to close a hole in my heart but not for artery issues.

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I am currently pregnant or breastfeeding.

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I have not had any surgery or interventional procedures within the last 30 days.

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My non-heart related illness may shorten my life to under a year.

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I am allergic to aspirin or heparin and cannot take similar medications.

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

THV dysfunction

Secondary study objectives

Device Success

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: TPVR- S3UR RegistryExperimental Treatment2 Interventions

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

Group II: TPVR - THV RegistryExperimental Treatment2 Interventions

Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.

Group III: TPVR - Main CohortExperimental Treatment1 Intervention

Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).

0 / 9Eligibility 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 treatments for congenital heart defects (CHDs) include surgical repair, catheter-based interventions, and transcatheter valve replacements. Surgical repair involves physically correcting the defect through open-heart surgery, which can be invasive and require significant recovery time. Catheter-based interventions, such as balloon angioplasty or stent placement, use a catheter to open narrowed vessels or repair defects without open surgery. Transcatheter valve replacements, like the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA, involve implanting a new valve via a catheter, which is less invasive than traditional surgery. These treatments are crucial for CHD patients as they offer less invasive options with potentially shorter recovery times and reduced risks, improving overall outcomes and quality of life.

Future Perspectives in Percutaneous Treatment of Tricuspid Regurgitation.Transcatheter Intervention for Congenital Defects Involving the Great Vessels: JACC Review Topic of the Week.[Surgery of complex congenital cardiopathies].