Long-term Survival After Single-ventricle Palliation

• Conditions: Heart Defects, Congenital

• Registration Number: NCT03356574
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1994-01-01
• Study First Submitted: 2017-11-24
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-29
• Primary Completion: 2018-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	Until death or end of follow-up (December 31st 2017)

Trial Locations

Locations (2)

Pediatric Heart Center, Queen Silvia Children's Hospital; 🇸🇪 Gothenburg, Sweden

Pediatric Heart Center, Lund University Hospital; 🇸🇪 Lund, Sweden