What side effects are associated with this type of intervention?

Common treatments for Tetralogy of Fallot, particularly those involving pulmonary valve replacement and RVOT reconstruction, include surgical procedures such as complete intracardiac repair and the use of prosthetic valves or conduits. Known side effects of these treatments can include arrhythmias, residual or recurrent pulmonary valve regurgitation, right ventricular dysfunction, bleeding, infection, and the need for re-intervention due to valve degeneration or conduit obstruction. Long-term follow-up is essential to monitor and manage these potential complications.

What prior FDA approvals exist?

The FDA has approved several treatments for Tetralogy of Fallot, particularly focusing on pulmonary valve replacement and RVOT reconstruction. Notable approvals include the Melody Transcatheter Pulmonary Valve (TPV) and the Edwards SAPIEN XT Transcatheter Heart Valve, both designed for percutaneous valve replacement in patients with dysfunctional RVOT conduits. These devices offer less invasive alternatives to open-heart surgery, providing significant benefits in terms of recovery and outcomes for patients with congenital heart defects like Tetralogy of Fallot.

What other types of research exist?

Promising alternatives to the GORE PV1 Device for Tetralogy of Fallot patients include the Melody Transcatheter Pulmonary Valve (TPV) and the Edwards SAPIEN XT Transcatheter Heart Valve. Both devices have shown positive outcomes in clinical trials for pulmonary valve replacement and RVOT reconstruction. The Melody TPV is known for its minimally invasive approach and suitability for pediatric patients, while the Edwards SAPIEN XT offers a robust design with proven durability.

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Prosthetic Device

GORE PV1 Device for Pulmonary Valve Dysfunction

N/A

Waitlist Available

Led By Pedro del Nido, MD

Research Sponsored by W.L.Gore & Associates

Eligibility Criteria Checklist

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

Must have

Age ≥5 years at the time of informed consent signature.

A symptomatic or appropriate asymptomatic subject with a native or repaired right ventricular outflow tract requiring reconstruction with a valved conduit

Must not have

Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year

An artificial valve at another position or will need an artificial valve at another position (i.e. replacement at the time of index procedure or anticipated within 3 years)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3, 6, 12, 24, 36, 48, and 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of the GORE PV1 Device, which is used to replace a damaged heart valve and repair a part of the heart. It targets patients who need their pulmonary valve replaced and their Right Ventricular Outflow Tract fixed. The device helps the heart pump blood more efficiently by taking over the function of the damaged valve and repairing the heart's structure.

Who is the study for?

This trial is for individuals aged 5 or older with a congenital heart defect requiring pulmonary valve replacement or RVOT reconstruction. It's not suitable for those with artificial valves elsewhere, pacemakers, or severe non-cardiac diseases like liver failure, renal failure, or cancer with a life expectancy under one year.

What is being tested?

The GORE PV1 Device is being tested in this study to see if it's safe and effective for replacing the pulmonary valve and reconstructing the Right Ventricular Outflow Tract (RVOT) in patients with certain heart conditions.

What are the potential side effects?

Potential side effects are not explicitly listed but may include complications related to device implantation such as infection, bleeding, arrhythmia, or issues specific to heart valve devices like clotting.

Eligibility Criteria

Inclusion Criteria

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

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I am 5 years old or older.

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I need surgery for a heart valve issue due to symptoms or a doctor's advice.

Exclusion Criteria

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

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I do not have a major illness with a life expectancy of less than one year.

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I have or will need an artificial valve replacement soon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3, 6, 12, 24, 36, 48, and 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3, 6, 12, 24, 36, 48, and 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 12, 24, 36, 48, and 60 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Valve-related mortality and device-related re-intervention

Secondary study objectives

All-cause mortality at 1, 3, 6, 12, 24, 36, 48, and 60 months

Device-related re-intervention at 1, 3, 6, 12, 24, 36, 48, and 60 months

Echo change in left ventricular end diastolic volume index at 12 months

+11 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Participants will receive the device on Day 1.

0 / 4Eligibility 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 Tetralogy of Fallot (TOF) involve surgical interventions to correct the structural heart defects. These typically include closing the ventricular septal defect and relieving the obstruction in the right ventricular outflow tract (RVOT). The GORE PV1 Device, which focuses on pulmonary valve replacement and RVOT reconstruction, is particularly important for TOF patients as it addresses pulmonary stenosis. This improves blood flow from the right ventricle to the lungs, reduces right ventricular hypertrophy, and enhances overall cardiac function, which is essential for the patient's long-term health and quality of life.