NCT01659411

Adult Congenital Heart Disease Registry (QuERI)

Adult Congenital Heart Disease Quality Enhancement Research Initiative

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, observational, U.S.-based longitudinal program. Data will be collected prospectively for 3 years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital Heart Disease (CHD).

Detailed description

Approximately 800 male and female adult patients with a history of repaired CHD will be recruited from approximately 100 cardiology practices and will be followed up every twelve months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Two groups of subjects will be enrolled based on identical exclusion criteria and inclusion criteria, with the exception only of inclusion criteria #3: cohort 1- those demonstrating historic high risk criteria and cohort 2 - those demonstrating current high risk criteria.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	Observational	Yearly clinical visits

Timeline

• Start date: 2011-12-01
• Primary completion: 2018-05-16
• Completion: 2018-05-16
• First posted: 2012-08-07
• Last updated: 2025-02-03