Image

Allogeneic Valve Transplantation

Recruiting
30 - 50 years of age
Both
Phase N/A

Powered by AI

Overview

Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

Description

Heart valves in children and young adults may need replacement or repair. In many children the options for heart valve replacement do not grow as the child grows. A transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. This trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. The study will look at outcomes of valve transplant and any potential side effects.

Eligibility

The proposed indications include:

  • Patients requiring aortic or pulmonary valve replacement.
  • Pediatric patients 30 days or older and < 18 years, and adult patients 18-50 yrs.
    • Particularly patients with significant growth potential
  • Insufficient options are available for valve replacement
    • Patients at risk of immunogenic bio-prosthetic valve failure
  • Discussion with patient /family - option for durable valve rather than traditional

    prosthesis

  • ABO compatible
  • Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization
  • Patients that are able to maintain follow-up at BCH during the duration of the study
  • Patients that are able to provide medical record authorization for 5 year follow-up

The proposed contraindications include:

  • Age < 30 days
  • Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely
  • Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic)
  • Morbid obesity (BMI>35)
  • Diabetes mellitus with evidence of end-organ damage
  • Severe chromosomal, neurologic or syndromic abnormalities
  • Immunocompromised condition (DiGeorge, SCID etc.)
  • Active infection
  • History of endocarditis
  • HIV or chronic hepatitis B or C infection
  • Malignancy within 5 years prior to transplant
  • Severe renal or liver failure
  • Inadequate social support for post-transplant management
  • Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior
  • Evidence of large stroke with high risk for hemorrhagic conversion
  • Heart transplant recipient
  • Patients that are unable to follow-up during the initial 6 month window
  • Patients that are unable to provide medical record authorization for 5 years

Study details

Valve Heart Disease, Valve Disease, Heart, Valve Disease, Aortic

NCT06387446

Boston Children's Hospital

18 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.