Congenital Heart Surgeons' Society (CHSS) Studies in Congenital Heart Disease

M
Mark Turrentine, MD

Primary Investigator

Enrolling By Invitation
All
Phase N/A
1 Location

Brief description of study

What is the purpose of this study?
The purpose of this study is to participate in a registry of patients with congenital heart disease. Patient data from the United States, Canada, and South America (whose institutions of care are members of the Congenital Heart Surgeon’s Society) will be submitted to this registry database.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be identified as they are referred to the study physicians for care of their congenital heart defect. Subjects will also be identified through a medical records review for the specific eligibility criteria of each study. Subjects identified as they present to the physician investigators for care of their heart condition will be contacted in a face to face manner. Subjects identified through medical records review will be contacted initially by telephone.

Detailed description of study

What will happen during the study?
No clinical procedures or tests are being performed for research purposes for this study. Subjects/subjects’ parents are being asked permission to share their/their child’s medical information with CHSS Data Center.
 
Currently there are 4 studies being conducted by the CHSS that we are participating in at this site:
STUDY TITLE: TRICUSPID ATRESIA 
STUDY TITLE: PULMONARY CONDUIT (Closed to Accrual – follow-up only) 
STUDY TITLE: ANOMALOUS AORTIC ORGIN OR A CORONARY ARTERY (AAOCA) 
STUDY TITLE: ATRIOVENTRICULAR SEPTAL DEFECT 
 
Patients eligible for any of these 4 studies will be included. The overall process for patients and sites participating in the studies are the same for all studies.
 
Data on subjects with congenital heart disease fitting the inclusion/exclusion criteria of the various studies will be obtained from the medical records by the local research staff and sent to the CHSS Data Center at the Hospital for Sick Kids in Toronto, Canada. Personnel from CHSS will enter the data from the source documents into the CHSS database. Periodically as subjects return for additional heart related procedures, the additional information is sent to CHSS.
 
Long-term follow-up: Subjects will be followed indefinitely on an annual basis from date of enrollment. Follow-up of all living subjects is done each year by the CHSS Data Center staff. Each year the subject/subject’s parents are sent a follow-up form to complete. Subject/subject’s parents will also be sent questionnaires to complete. The questionnaire data collection will be done using non-standardized CHSS Data Center questionnaires and standardized questionnaires including the PedsQL quality of life and cardiac modules. The package includes a stamped self-addressed envelope but may also return the forms via fax or electronically. Subjects/subjects’ parents also have the option to complete the form/questionnaires over the phone by calling the CHSS toll free number and speaking with a trained research assistant.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Congenital Heart Disease
  • Gender: All

TRICUSPID ATRESIA STUDY: Inclusion Criteria: • Diagnosis of tricuspid atresia with normally related great arteries AND • Age < 3 months at time of diagnosis AND • Admitted to a CHSS institution after January 1, 1999, i.e., birthdate after October 1, 1998 PULMONARY CONDUIT STUDY – Closed to Accrual Inclusion Criteria: • Valved Conduit Implant at age <2 years at member institution. Date of first implant AFTER January 1, 2002. (Note: Patients who have 1.5 ventricle repair (eg CCTGA) are included) AND • Survival to hospital discharge after conduit insertion AND • First pulmonary ventricle-pulmonary ventricle-pulmonary artery conduit placement AND • Informed consent from patient’s parent or guardian ANOMALOUS AORTIC ORIGIN OF A CORONARY ARTERY (AAOCA) Inclusion Criteria: • Diagnosis and/or management of AAOCA at a CHSS member institution from January 1, 1998 forward • Male or female age 0-30 years at time of diagnosis • If surgical repair: o Performed from January 1, 1998 to study initiation (January 20, 2009) for retrospective subjects o Performed from January 21, 2009 forward for prospectively identified subjects o Completed operative note • Structurally normal heart or heart with small, hemodynamically insignificant lesion, including: patent ductus arteriosus, atrial septal defect, ventricular septal defect, mild pulmonic valvar stenosis, or bicuspid aortic valve without aortic stenosis. • Parental/guardian permission (informed consent, and authorization as applicable), subject consent and authorization as applicable if > 18 years of age and if appropriate, child assent for the observational/questionnaire portion of the study. ATRIOVENTRICULAR SEPTAL DEFECT Inclusion Criteria: 1. Diagnosis of or referral with complete AVSD at a CHSS member institution within first year of life 2. Admitted to CHSS institution for surgery after January 1, 2012 3. Age < 365 days at admission for surgery 4. Atrioventricular and Ventriculoarterial concordance (Includes Tetralogy of Fallot or Double Outlet Right Ventricle) 5. Informed written consent, as applicable. Patients who meet the eligibility criteria but are known to have passed away before being consented will be enrolled in the study. However, their families will not be contacted for consent, follow-up, or for any other study related purpose.

 
TRICUSPID ATRESIA STUDY: Exclusion Criteria: • Patients with atrioventricular (AV) or ventriculoarterial (VA) discordance OR • First intervention at non-CHSS institution OR • Age > 3 months at time of diagnosis, i.e., birthdate before October 1, 1998. PULMONARY CONDUIT STUDY – Closed to Accrual Exclusion Criteria: • Single ventricle RV-PA Conduit (e.g. Norwood RV-PA conduit) • VSD fenestrated or not closed • Non-valved conduit ANOMALOUS AORTIC ORIGIN OF A CORONARY ARTERY (AAOCA) Exclusion Criteria: • Anomalous coronary from the pulmonary artery, coronary artery atresia, or other coronary artery anomalies (e.g., coronary-cameral fistula, coronary aneurysms, myocardial bridging) • Hemodynamically significant structural heart disease, except as outlined above. ATRIOVENTRICULAR SEPTAL DEFECT Exlcusion Criteria: 1. Partial or Transitional AVSD (Separate AV valve orifices, restrictive VSD or intact ventricular septum) 2. Total or Partial Anomalous Pulmonary Venous Drainage (TAPVC or PAPVC) 3. Aortic atresia 4. Heterotaxy 5. First Intervention at a non-CHSS institution. Patients who meet the eligibility criteria but are known to have passed away before being consented will be enrolled in the study. However, their families will not be contacted for consent, follow-up, or for any other study related purpose.

Updated on 08 Apr 2025. Study ID: SURG-CHSS-TURRENTINE-CHD, 1011003020
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