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Long-term Survival After Single-ventricle Palliation

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ClinicalTrials.gov Identifier: NCT03356574
Recruitment Status : Unknown
Verified February 2019 by Magnus Dalén, Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 29, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Queen Silvia Children's Hospital, Gothenburg, Sweden
Lund University Hospital
Information provided by (Responsible Party):
Magnus Dalén, 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.

Condition or disease Intervention/treatment
Heart Defects, Congenital Procedure: Single-ventricle palliation surgery

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study
Actual Study Start Date : January 1, 1994
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Survival [ Time Frame: Until death or end of follow-up (December 31st 2017) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Children operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356574


Locations
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Sweden
Pediatric Heart Center, Queen Silvia Children's Hospital
Gothenburg, Sweden
Pediatric Heart Center, Lund University Hospital
Lund, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Queen Silvia Children's Hospital, Gothenburg, Sweden
Lund University Hospital
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Responsible Party: Magnus Dalén, MD, PhD, Principal Investigator, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03356574    
Other Study ID Numbers: Single-ventricle survival
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases