Pulmonary Valve Replacement Surgery for Heart Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Boston Children's Hospital, Boston, MA
Heart Diseases+2 More
Pulmonary Valve Replacement Surgery - Device
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether the Autus Size-Adjustable Valve is safe and effective in children.

See full description

Eligible Conditions

  • Heart Diseases
  • Congenital Heart Disease (CHD)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Pulmonary Valve Replacement Surgery will improve 4 primary outcomes and 25 secondary outcomes in patients with Heart Diseases. Measurement will happen over the course of 30 days.

12 Months
Valve Implantation Primary Effectiveness Endpoint
12 months
Valve Implantation Primary Safety Endpoint
30 days
Post-implant Valve Expansion Primary Safety Endpoint
Year 5
Secondary Effectiveness Echo-Related Endpoint - Freedom from Moderate or Greater Pulmonary Regurgitation
Secondary Effectiveness Echo-Related Endpoint - Left Ventricular Measures
Secondary Effectiveness Echo-Related Endpoint - Paravalvular Leak
Secondary Effectiveness Echo-Related Endpoint - Pulmonary Regurgitation
Secondary Effectiveness Echo-Related Endpoint - Pulmonary Stenosis Status
Secondary Effectiveness Echo-Related Endpoint - RV to PA systolic pressure gradient - multi-level assessment via Continuous Wave (CW) Doppler
Secondary Effectiveness Echo-Related Endpoint - RV to PA systolic pressure gradient - multi-level assessment via Pulsed Wave (PW) Doppler
Secondary Effectiveness Echo-Related Endpoint - Right Ventricular Measures
Secondary Effectiveness Endpoint - Modified Ross Functional Classification
Year 6
Secondary Safety Endpoint - Adverse Events (AE)
Secondary Safety Endpoint - Device Explantation
Secondary Safety Endpoint - Device-related
Secondary Safety Endpoint - Endocarditis
Secondary Safety Endpoint - Hemolysis
Secondary Safety Endpoint - Major Hemorrhage
Secondary Safety Endpoint - Mortality
Secondary Safety Endpoint - Reintervention
Secondary Safety Endpoint - Structural Valve Deterioration
Secondary Safety Endpoint - Thromboembolism
Secondary Safety Endpoint - Thrombosis
Secondary Safety Endpoint - Valve/stent Frame Fracture
6 months
Post-implant Valve Expansion Primary Effectiveness Endpoint
Year 5
Secondary Effectiveness Endpoint - Valve/Stent Fracture
Immediately Post-Valve Implant Procedure
Secondary Effectiveness Endpoint-Valve Implant Acute Procedural Success
Immediately after each post-implant valve expansion procedure
Secondary Effectiveness Endpoint - Change in Cardiac Index Post-Implant Valve Expansion
Secondary Effectiveness Endpoint - Post-Implant Valve Expansion Acute Procedural Success

Trial Safety

Trial Design

1 Treatment Group

Autus Valve Arm
1 of 1
Experimental Treatment

This trial requires 15 total participants across 1 different treatment group

This trial involves a single treatment. Pulmonary Valve Replacement Surgery is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Autus Valve Arm
Device
Pulmonary Valve Replacement Surgery with the Autus Valve

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: annually through 5 years post-valve implant and 12 months post-valve expansion.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly annually through 5 years post-valve implant and 12 months post-valve expansion. for reporting.

Closest Location

Boston Children's Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
Age 2 to 10 years inclusive (± 6 months).
Male or female.
Subject has a native or repaired right ventricular outflow tract.
Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
Moderate or greater pulmonary regurgitation (defined as (vena contracta jet width/square root of BSA) ≥2.98 mm/m2).
Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
Subject's pulmonary artery length is adequate for implantation of the study device.

Patient Q&A Section

Can heart defects, congenital be cured?

"After reviewing the cases of the 9 individuals with congential heart defects reported to the Western Australia State Department of Health in 1992-1994 we find that 4 of the individuals died during the first 6 months of life. None of the individuals who succumbed to congential heart defects were subjected to a heart transplant. We conclude that survivors of congential heart defects are likely to suffer multiple sequelae rather than cure. The role of the paediatric cardiologist in such groups is uncertain but it might be that they play a role in deciding on medical management as well as in educating parents on the prognostic factors as well as the benefits and risks of treatment." - Anonymous Online Contributor

Unverified Answer

What are the signs of heart defects, congenital?

"Signs typically include asymmetry of the face with asymmetrical or unequal nostrils, enlarged tongue with an upward and downward bulge, and the presence of a fistula. Other signs of heart defects, congenital may be present, but are more subtle. The most common heart defect, cleft palate, may be not noticed at the time of birth, leading to delay for diagnosis. The signs of cleft lip with or without cleft palate may also be present." - Anonymous Online Contributor

Unverified Answer

What causes heart defects, congenital?

"heart defects can have many reasons including chromosomal anomalies, or a mixture of both genetic and environmental factors. A number of diseases can cause heart defects like: Down Syndrome, trisomic trisomy mosaicism, Turner syndrome and Prader-Willi syndrome. Congenital heart defects can also be caused by defects in the embryonic development of the heart. Many defects can cause pulmonary hypertension and are often associated with genetic conditions such as Noonan/Patau complex syndrome. Congenital heart defects can also have multiple causes, which include syndromic heart anomalies, genetic syndromes or single-gene defects." - Anonymous Online Contributor

Unverified Answer

What is heart defects, congenital?

"In comparison to typical populations, heart defects, congenital are more often encountered in a large proportion of patients with schizophrenia. The frequency of heart defects, congenital is 1.8 times higher in patients with schizophrenia." - Anonymous Online Contributor

Unverified Answer

What are common treatments for heart defects, congenital?

"Current treatment options for some congenital heart defects are tailored to patient-specific requirements. Commonly pursued interventions include surgery, catheter-based therapies, and heart failure therapies. In a minority of patients, heart valve and/or outflow tract defects may not be surgically repairable and may be managed by alternative therapy(s) such as catheter-based therapies or medications." - Anonymous Online Contributor

Unverified Answer

How many people get heart defects, congenital a year in the United States?

"More than 80,000 children in the United States are born with a heart defect. This makes it the most common birth defect in the United States. Congenital heart defects are most prevalent in males. theme:

Cultural practices can affect the rates in which individuals with disabilities or long-term conditions die. For example, people in nations in which the law places greater importance on a child's education may be more likely to die in later life if educated through their disability.\n\nThere are many ways in which individuals may have their lifespan shortened as a result of disability." - Anonymous Online Contributor

Unverified Answer

How serious can heart defects, congenital be?

"Heart or thoracic abnormalities like CHD are associated with several other comorbidities which are serious enough to warrant attention and treatment, but most importantly with [premature death], especially if not detected in childhood." - Anonymous Online Contributor

Unverified Answer

How does pulmonary valve replacement surgery work?

"The pulmonary valve replacement results in significant reductions in blood pressure after the procedure in an effort to help the heart pump blood to areas of increased peripheral vascular resistance. The most common side effect of surgery is the formation of a valve prolapse where a portion of an old or a faulty cardiac valve is expelled from the heart. This can be corrected by use of the surgeon's heart to plug this hole. Other complications may arise from complications that occur during surgery. The patient undergoes the procedure as a complete unit and is not removed from the operation room until the surgeon has finished completing the heart procedure. The amount of time spent in the operating room depends on the actual case load present." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets heart defects, congenital?

"As of 2000, the average age that someone will develop heart defects, congenital was reported as 8.0-7.5 year of age. A recent report states the average age as 2.5 year of age. This is reassuring because this is a critical period where heart defects may occur. When there is a family member with a heart defect, it is most likely to appear in later age. People should be checked and watched for any sign or symptoms. To find out if you have a family member who has had heart defects, look [power (power.com) to find out." - Anonymous Online Contributor

Unverified Answer

What is pulmonary valve replacement surgery?

"Pulmonary valve replacement surgery is a safe and effective procedure. It is a durable treatment for pulmonary stenosis. In symptomatic patients, the main indications for surgical intervention of symptomatic pulmonary regurgitation are worsening heart failure or exercise intolerance. In patients requiring concomitant repair of atrial septal defects, valve prolapse, and/or residual pulmonary stenosis, pulmonary valve replacement was more likely to be performed." - Anonymous Online Contributor

Unverified Answer

What is the latest research for heart defects, congenital?

"This article is an update for congenital heart defects. There is no single or standardized treatment for heart defects, and therapy depends on the complexity of the problem, the patient's presentation, the surgeon's expertise, and the general medical condition. In this article, we review heart defects and the treatment procedures used to help children with defects. Also, we update a list of surgeries that may be used for heart defects." - Anonymous Online Contributor

Unverified Answer

Is pulmonary valve replacement surgery typically used in combination with any other treatments?

"PVR was typically used in combination with other treatments in the study population in our experience. However, randomized, controlled, multicenter trials have shown that PVR can be administered alone if the cardiac valve function is maintained to a statistically equivalent condition. In addition, when performing other concomitant pulmonary artery procedures in a patient with a PVR, careful consideration should be given to the possible worsening of ventricular function." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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