Northwest Adult Congenital Heart Disease Observatory

Congenital Heart Disease Clinical Trial

— CARL  

Official title:

Northwest Inter Hospital Adult Congenital Heart Disease Observatory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02897323
• Other study ID #: 14-140
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2016
• Last updated: November 28, 2017
• Start date: November 14, 2016
• Est. completion date: October 2020

Study information

• Verified date: November 2017
• Source: University Hospital, Caen
• Contact: Fabien Labombarda
• Phone: 0231064767
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Other:
• description

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patients characteristics description	Obtain epidemiological data on adult congenital of the population followed in northwest region of France	baseline
Secondary	heart disease complications description		baseline
Secondary	complications during pregnancy description		baseline