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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