Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT00243776

Conditions

Congenital Heart Disease

Tetralogy of Fallot

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The study team will use small pieces of human hearts which are removed as part of a required surgical procedure to study different objectives. One of the objective is how calcium ions pass through the membrane of heart cells in order to tell the heart cell how much force to contract with when the heart beats. Investigators will also study the proteins and RNA of these pieces to determine how the newborn heart cells control their force of contraction differently from adult heart cells. Investigators hypothesize that infant hearts have different regulation of calcium entry than adult hearts. The study team also wants to study combinations of 3D cardiac spheres with multiple environmental cues that can improve functional and metabolic maturation of Human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) and generate a more clinically relevant cell model.

Conditions

Congenital Heart Disease

Tetralogy of Fallot

Study ID

NCT00243776

Start date

Apr, 2005

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients undergoing cardiopulmonary bypass surgery
  • Patients undergoing surgery for repair of congenital heart disease such as ventricular septal defect or defective mitral or aortic valves.

Exclusion Criteria:

  • Prior cardiac surgery
  • History of atrial fibrillation or other atrial arrhythmias prior to operation
  • History of heart failure

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

Cardiac Tissue

Cardiac tissue and cells will be obtained from participants undergoing cardiac surgical repair

Primary outcome measure

  • Calcium Current Measures [ Time Frame: Duration of Study (Up to 13 Years) ]
  • Change in structural, functional and metabolic maturation of Human pluripotent stem cell derived Cardiomyocytes (hPSC-CMs) [ Time Frame: Duration of Study (Up to 3 Years) ]

Central Contacts and Locations

Central contacts

Michael E Davis, PhD

404-727-9858medavis@emory.edu

Kati Miller

404-729-0492kati.miller@choa.org

Locations

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Mary B Wagner, PhD

More Information

Sponsor

Emory University

Last update posted

May 6, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-05-06.