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Clinical Trials/NCT02897323
NCT02897323
Unknown
Not Applicable

Northwest Inter Hospital Adult Congenital Heart Disease Observatory

University Hospital, Caen1 site in 1 country4,000 target enrollmentNovember 14, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congenital Heart Disease
Sponsor
University Hospital, Caen
Enrollment
4000
Locations
1
Primary Endpoint
patients characteristics description
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 14, 2016
End Date
October 2020
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

patients characteristics description

Time Frame: baseline

Obtain epidemiological data on adult congenital of the population followed in northwest region of France

Secondary Outcomes

  • heart disease complications description(baseline)
  • complications during pregnancy description(baseline)

Study Sites (1)

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