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NCT03356574 Clinical Trial

Long-term Survival After Single-ventricle Palliation

Heart Defects, Congenital Clinical Trial

Official title:
Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03356574
Other study ID # Single-ventricle survival
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 1994
Est. completion date December 31, 2019

Study information
Verified date February 2019
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A nationwide observational study. Children operated with single-ventricle palliation between January 1994 and December 2017 operated in Sweden will be included retrospectively. Patients born with a functionally single ventricle but not undergoing surgery will not be included. Data regarding preoperative clinical characteristics and operative details will be obtained by medical records review and from The Swedish Registry of Congenital Heart Disease (SWEDCON). Using unique personal identity numbers assigned to all residents of Sweden, data from SWEDCON will be linked with dates of death.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 800
Est. completion date December 31, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Single-ventricle palliation surgery
Single-ventricle palliation surgery

Locations
Country Name City State
Sweden Pediatric Heart Center, Queen Silvia Children's Hospital Gothenburg
Sweden Pediatric Heart Center, Lund University Hospital Lund

Sponsors (3)
Lead Sponsor Collaborator
Karolinska University Hospital Lund University Hospital, Queen Silvia Children's Hospital, Gothenburg, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Until death or end of follow-up (December 31st 2017)
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