Studies and Forms

Unbalanced Atrioventricular Septal Defect (uAVSD): A CHSS Inception Cohort Study

• Study Objectives and Enrollment Form
• Study Protocol
• Study Approval at The Hospital for Sick Children, Toronto
• Consent Form
• Data Collection Forms:

A. To be abstracted at the CHSS Data Center, Toronto

1. Basline Health Data
2. Surgical Form
3. Echo Form
4. Cardiac Catheterization Form

B. To be sent annually by the CHSS Data Center and completed by the patients/parents

1. Annual Follow-up Form

AAOCA: Anomalous Aortic Origin of a Coronary Artery study

• Study Objectives and Enrollment Form
• Study Protocol
• AAOCA Study Template Presentation for Research Review Committees
• Study re-approval at The Hospital for Sick Children, Toronto
• Assent Form
• Parental Consent Form (minor)
• Subject Consent Form (adults)
• Data Collection Forms:

A. To be abstracted at the CHSS Data Center, Toronto

1. Baseline Demographics
2. Diagnostic Tests
3. Hospitalization for Surgery
4. Ischemia tests
5. Pattern Diagram: Surgical View
6. Pattern Diagram: Imaging View

B. To be completed by the operating surgeon at participating institution

1. Surgical Details Checklist
2. Atomization Form

C. To be sent annually by the CHSS Data Center and completed by the patients/parents

1. Follow-up Questionnaire (Adult)
2. Follow-up Questionnaire (Child)

LVOTO: Critical Left Ventricular Outflow Tract Obstruction study

• Study Objectives and Enrollment Form
• LVOTO Introduction Letter
• Study Protocol
• Study re-approval letter at The Hospital for Sick Children, Toronto
• Parental Consent Form for study participation

PC: Pulmonary Conduit study

• Study Objectives and Enrollment Form
• Common Questions and Answers
• Study re-approval letter at The Hospital for Sick Children, Toronto
• Parental Consent Form for study participation

TA: Tricuspid Atresia study

• Study Objectives and Enrollment Form
• Study re-approval letter at The Hospital for Sick Children, Toronto
• Parental Consent Form for study participation

Data Sharing Agreement from The Hospital for Sick Children, Toronto

Template: Children's Mercy Hospital, Kansas City IRB Approval Process

Transposition of the Great Arteries (TGA) Study

Objectives:

• To assemble a multi-institutional inception cohort of neonates with Transposition of the Great Arteries.
• To compare survival outcomes of neonates age 2 weeks presenting with various forms of TGA.

From 1985 to 1989, 895 neonates with transposition of the great arteries were enrolled from 23 institutions.

Interrupted Aortic Arch (IAA) Study

Objectives:

• To determine outcomes for neonates with interruption of the aortic arch (IAA).
• To determine what patient management variables improve outcomes.

From 1987 to 1997, 474 neonates were enrolled prospectively from 33 institutions.

Coarctation Study

Objectives:

• To determine outcomes for neonates with coarctation of the aorta.
• To analyze the importance of different treatment strategies.

From 1990 to 1993, 965 neonates were enrolled prospectively from 32 institutions.

Pulmonary Atresia Intact Ventricular Septum (PAIVS) Study

Objectives:

• Determine the proportion of neonates reaching defined end-states (i.e. Bi-ventricular Repair, Fontan, Heart Transplant, One-and-a-half ventricle repair or death).
• Identify risk factors associated with end-state, including Bi-ventricular Repair Fontan, Heart Transplant, One-and-a-half ventricle repair or death).

From January 1987 to April 1997, 408 neonates with PAIVS admitted to a CHSS institution within 30 days after birth were prospectively enrolled in a multi-institutional study.  PAIVS was defined as no communication between the right ventricle (RV) and pulmonary trunk and absence of ventricular septal defect (VSD) as determined by echocardiographic, catheterization, or surgical findings.

Pulmonary Stenosis with Intact Ventricular Septum (PSIVS) Study

Objectives:

• To determine outcomes and associated patient and management factors for neonates with pulmonary stenosis with intact ventricular septum.
• To observe the transition from surgical to percutaneous management.

From 1987 to 1993, 193 neonates were enrolled prospectively from 27 institutions.