Congenital Heart Disease Clinical Trial
— CHAINOfficial title:
Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography
Verified date | February 2014 |
Source | Hospital do Coracao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.
Status | Completed |
Enrollment | 2000 |
Est. completion date | December 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day and older |
Eligibility | Inclusion Criteria: - Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Exclusion Criteria: - Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization. |
Country | Name | City | State |
---|---|---|---|
Brazil | Otavio Berwanger | Sao Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital do Coracao | Ministry of Health, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of serious complications of cardiac catheterization in congenital heart | Occurrence of serious complications of cardiac catheterization in congenital heart procedure-related (occurring within 7 days after the procedure or until hospital discharge, whichever occurs first, and following 30 days), such as embolization of the prosthesis, cardiac arrhythmias, trauma vascular intracardiac injury, death, etc | December 2014 |
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