Allogeneic Valve Transplantation

NCT06387446 | Recruiting DMC

• 1 other identifier: RB-P00044611
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Valve Regurgitation

  Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.

  One year

• Valve Annulus Growth

  Measurement of valve annulus via echocardiogram, CT scan and MRI. This will be quantified by whether or not the annulus continues to increase in size as the subject grows.

  One Year

• Leaflet Growth

  Measurement of leaflet height via echocardiogram, CT scan and MRI and reviewed by an echocardiologist. This will be analyzed by whether or not the leaflets continue to grow in size, with the subject.

  One Year

Secondary Outcomes (2)

• Ventricular Function

  One year

• Survival

  5 years

Study Arms (1)

Valve transplantation group

EXPERIMENTAL

This arm undergoes Allogeneic Valve transplantation

Procedure: Valve transplant

Interventions

Valve transplant PROCEDURE

Heart valves from an organ donor will be transplanted into recipient

Valve transplantation group

Eligibility Criteria

• Age: 30 Days - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sitaram Emani, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sitaram Emani, MD

CONTACT

6173557899; sitaram.emani@cardio.chboston.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)