What side effects are associated with this type of intervention?

Common treatments for Tetralogy of Fallot, particularly those involving Right Ventricular Outflow Tract Reconstruction (RVOTR) such as surgical repair and valve replacement, can have several side effects. These may include arrhythmias, residual or recurrent pulmonary valve regurgitation, right ventricular dysfunction, and potential need for re-intervention. Other risks include infection, bleeding, and complications related to the use of prosthetic materials or devices.

What prior FDA approvals exist?

The FDA has approved various treatments for Tetralogy of Fallot, primarily focusing on surgical interventions such as complete surgical repair, which includes procedures like ventricular septal defect closure and right ventricular outflow tract reconstruction. Devices similar to those being studied in the MASA Valve trial, such as pulmonary valve replacement devices, have also been approved. These devices aim to improve the function of the right ventricular outflow tract and are crucial for patients requiring reconstruction due to congenital heart defects.

What other types of research exist?

Promising novel alternatives to the MASA Valve for RVOTR in Tetralogy of Fallot patients include the Melody Transcatheter Pulmonary Valve and the Edwards SAPIEN XT Transcatheter Heart Valve. Both devices have shown positive outcomes in clinical trials for RVOTR and are minimally invasive options that can be considered for patients requiring pulmonary valve replacement.

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Prosthetic Valve

New Valve Surgery for Heart Valve Defects (MVEFS Trial)

N/A

Recruiting

Led By David Morales, MD

Research Sponsored by PECA Labs

Eligibility Criteria Checklist

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

Must have

Age < 22 years

At least one of the following: Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis

Must not have

Patient has a need for concomitant surgical procedures (non-cardiac)

Need for emergency cardiac or vascular surgery or intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the MASA Valve, a special tube with a valve, in young patients with specific heart defects. The valve helps create a new path for blood to flow from the heart to the lungs and prevents backflow. The goal is to see if this device is safe and beneficial for these patients.

Who is the study for?

This trial is for children and young adults under 22 with certain heart conditions needing surgery to fix blood flow from the right ventricle to the pulmonary artery. They must be able to return for follow-ups, have a legal guardian's consent, and not be involved in other drug/device trials or have severe non-cardiac diseases.

What is being tested?

The MASA Valve Early Feasibility Study tests a new device called MASA Valve in patients requiring surgical reconstruction of the pathway from the heart's right ventricle to the lung arteries (RVOTR). It aims to assess safety and potential benefits as preliminary research before larger studies.

What are the potential side effects?

While specific side effects are not listed, typical risks may include reaction to materials in the device, complications from heart surgery like bleeding or infection, and potential need for future surgeries if issues arise with valve function.

Eligibility Criteria

Inclusion Criteria

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

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I am younger than 22 years old.

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I have severe heart valve issues needing a replacement.

Exclusion Criteria

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

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I need surgery for a condition that is not related to my heart.

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I need emergency heart or blood vessel surgery.

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I have a severe chest wall deformity that prevents certain medical procedures.

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I have an ongoing heart infection.

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I have an autoimmune disease or am taking drugs that affect my immune system.

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

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

Freedom from Device-Related Catheter Intervention

Freedom from Device-Related Reoperation

Freedom from Endocarditis

+4 more

Secondary study objectives

Freedom from Moderate or Greater Pulmonary Regurgitation

Freedom from Pulmonary Gradient ≥36mmHg

Freedom from device valve failure

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: Experimental ArmExperimental Treatment1 Intervention

This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.

0 / 8Eligibility 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

Tetralogy of Fallot (TOF) treatments often involve surgical interventions to correct anatomical defects, particularly focusing on relieving right ventricular outflow tract (RVOT) obstruction. The MASA Valve trial, which studies a device for RVOT reconstruction, is significant for TOF patients as it directly addresses this obstruction. By relieving RVOT obstruction, these treatments reduce right ventricular pressure and improve blood oxygenation, thereby restoring normal blood flow dynamics and reducing the risk of complications such as right ventricular hypertrophy and heart failure.