Northwest Adult Congenital Heart Disease Observatory

• Conditions: Congenital Heart Disease

• Registration Number: NCT02897323
• Lead Sponsor: University Hospital, Caen

Brief Summary

The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-29
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-11-14
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-30
• Primary Completion: 2019-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Patient, male or female, aged 18 years
• Congenital heart disease operated or non-operated
• Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France

Exclusion Criteria

• Patient refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patients characteristics description	baseline	Obtain epidemiological data on adult congenital of the population followed in northwest region of France

Secondary Outcome Measures

Name	Time	Method
heart disease complications description	baseline
complications during pregnancy description	baseline

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France