Download Critical Left Ventricular Outflow Tract Obstruction Study

Critical Left Ventricular Outflow Tract Obstruction Study
PATIENT ENROLLMENT FORM
OVERALL GOAL AND OBJECTIVES
Assemble a multi-institutional inception cohort of infants with critical LVOTO undergoing all currently available treatment strategies
Identify risk factors that are predictive of late outcomes
Determine the value of emerging management strategies
Assess late outcomes by functional assessment, quality of life, developmental outcomes & identify electrophysiological complications
INCLUSION CRITERIA
Age < 30 days at admission to a CHSS institution and
Date of Admission AFTER December 31, 2004 and
AV & VA concordance whose LVOTO precludes an adequate systemic cardiac output through the aortic valve and
(include Critical LVOTO due to either aortic valve stenosis OR anatomically normal but hypoplastic left heart)
Informed consent from patient’s parent or guardian
Note: 1. Patients with a VSD will be included; 2. Patients who meet the criteria but have died prior to surgery will be included
EXCLUSION CRITERIA
First intervention at a non-CHSS institution
AV or VA discordance
Atrioventricular Septal Defect
To be completed by Enrollment Institution, for EACH patient being enrolled
Patient Name: ____________________________________ Date of Birth: ___________________________________________
Parents’ Name: __________________________________
Death Date (if applicable):_________________________________
Address: ________________________________________
Gender: ________________
Race: _________________
________________________________________________ Birth Weight: ______________
Birth Height: _______________
Phone: _________________________________________
Email address: ___________________________________
Surgeon: ______________________________________________
Hospital Name: ___________________________________ Cardiologist: ____________________________________________
Medical Record Number: __________________________
Family Doctor: ___________________________________________
Cardiac Diagnosis: ___________________________________________________________________________________________
WHAT NEEDS TO BE SENT FOR EACH PATIENT?
Copy of signed consent
A copy of the initial echo images on CD
Admission Slip or equivalent for demographic information
Admission note
All cardiac operative reports (including sternal openings/
closings and ECMO with perfusions sheet & anesthetic flow
sheets
Echo report (pre & post cardiac procedures)
Discharge summaries
Cardiac Catheterization Reports
Cardiac Clinic letters
Autopsy report / Death report (if applicable)
FOR CHSS DATA CENTER USE ONLY
Study Number:
_________________
555 University Avenue
Toronto, ON, Canada M5G1X8
TOLL FREE: 1-866-477-CHSS (2477)
Fax: 416-813-8776
Website: www.chssdc.org
Email: [email protected]
[Type text]
Registration Date:
CHSS DATA CENTER STAFF
William G. Williams, MD
Executive Director
Christopher Caldarone, MD
Managing Director
STATISTICAL CONSULTANTS
Brian McCrindle, MD, MPH
Eugene Blackstone, MD
_______________
Enrolled by:
Travis Wilder, MD
Kirklin/Ashburn Fellow
Maulik Baxi, MD, MPH
Research Program Manger
Sally Cai, MSc
Database Manager
___________________
CLINICAL RESEARCH
NURSE COORDINATORS
Susan McIntyre, RN
Veena Sivarajan, RN
CLINICAL RESEARCH
PROJECT ASSISTANTS
Annette Flynn
Christina Faber
Version date: 2013-07-01