A Prospective Data Registry for the Congenital Cardiovascular Interventional Study Consortium: Risk Stratification for Cardiac Catheterization Procedures
Clinical Trial Information
Trial Contact: Cowden, Amanda
Trial Phone: 321.841.5365
IRB No: 08.066.06
Protocol Abbrev: CCISC
Principal Investigator: David Gordon Nykanen, MD
Sub Investigators: Schwartz, Matthew MD; Farias, Michael MD
Age Group: Adult; Neonate
Applicable Disease Sites: Cardiac catheterization
1. To determine the incidence of serious adverse events in cardiac catheterization procedures in the current era utilizing a multi-centered registry.
2. To validate a method of risk stratification for cardiac catheterization.
3. To mathematically model adverse event occurrence in quality assurance assessments.
a) Any person undergoing a cardiac catheterization in a congenital heart center.
b) Hybrid procedure wherein the surgical component represents obtaining an alternative route of vascular access only.