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Long-term Survival After Single-ventricle Palliation

NCT ID: NCT03356574

Last Updated: 2019-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

1994-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Defects, Congenital

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Single-ventricle palliation surgery

Single-ventricle palliation surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Silvia Children's Hospital, Gothenburg, Sweden

OTHER

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Dalén

MD, PhD, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Heart Center, Queen Silvia Children's Hospital

Gothenburg, , Sweden

Site Status

Pediatric Heart Center, Lund University Hospital

Lund, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38497454 (View on PubMed)

Other Identifiers

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Single-ventricle survival

Identifier Type: -

Identifier Source: org_study_id

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