Recruiting

Allogeneic Valve

Sponsor:

Boston Children's Hospital

Code:

NCT06387446

Conditions

Valve Heart Disease

Valve Disease, Heart

Valve Disease, Aortic

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Interventions

Valve transplant

Study Details

Brief summary:

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

Conditions

Valve Heart Disease

Valve Disease, Heart

Valve Disease, Aortic

Study ID

NCT06387446

Start date

May 1, 2024

Status verified date

Sep, 2024

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement.
  • Pediatric patients 30 days or older and < 18 years, and adult patients 18-50 yrs.

o Particularly patients with significant growth potential
  • Insufficient options are available for valve replacement

o 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

Exclusion Criteria

  • 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 Design

Enrollment

4 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Valve transplantation group

This arm undergoes Allogeneic Valve transplantation

Interventions

Valve transplant

Heart valves from an organ donor will be transplanted into recipient

Primary outcome measure

  • Valve Regurgitation [ Time Frame: One year ]
  • Valve Annulus Growth [ Time Frame: One Year ]
  • Leaflet Growth [ Time Frame: One Year ]

Central Contacts and Locations

Central contacts

Sitaram Emani, MD

6173557899sitaram.emani@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Boston Children's Hospital

Last update posted

Sep 24, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2024-09-24.