NCT03356574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1994

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1994

Completed
23.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

25 years

First QC Date

November 24, 2017

Last Update Submit

February 25, 2019

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

  • Survival

    Until death or end of follow-up (December 31st 2017)

Interventions

Single-ventricle palliation surgeryPROCEDURE

Single-ventricle palliation surgery

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pediatric Heart Center, Queen Silvia Children's Hospital

Gothenburg, Sweden

Location

Pediatric Heart Center, Lund University Hospital

Lund, Sweden

Location

Related Publications (1)

  • Dalen M, Odermarsky M, Liuba P, Johansson Ramgren J, Synnergren M, Sunnegardh J. Long-Term Survival After Single-Ventricle Palliation: A Swedish Nationwide Cohort Study. J Am Heart Assoc. 2024 Mar 19;13(6):e031722. doi: 10.1161/JAHA.123.031722. Epub 2024 Mar 18.

    PMID: 38497454DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Principal Investigator

Study Record Dates

First Submitted

November 24, 2017

First Posted

November 29, 2017

Study Start

January 1, 1994

Primary Completion

December 31, 2018

Study Completion

December 31, 2019

Last Updated

February 26, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)