Heart Defects, CongenitalNCT03356574
Long-term Survival After Single-ventricle Palliation
An observational study of Heart Defects, Congenital, run by Karolinska University Hospital at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Heart Defects, Congenital
- What is being tested?
- Single-ventricle palliation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Jan 1994to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Children operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.
Who may be able to join
- Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Pediatric Heart Center, Queen Silvia Children's Hospital
Gothenburg
Pediatric Heart Center, Lund University Hospital
Lund
About this study
Official title: Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study
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.
- Conditions
- Heart Defects, Congenital
- Being tested
- Single-ventricle palliation surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-ventricle palliation surgeryProcedure or surgery
Single-ventricle palliation surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: Until death or end of follow-up (December 31st 2017)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Jan 1994
- Primary completion31 Dec 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Silvia Children's Hospital, Gothenburg, Sweden, Lund University Hospital
- Responsible party
- Principal investigator, Magnus Dalén, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356574
- Sponsor's protocol ID
- Single-ventricle survival
- Status last verified
- Feb 2019
- First submitted
- 24 Nov 2017
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38497454
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Survival After Single-ventricle Palliation: A Swedish Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT03356574
- Acronym / sponsor ID
- Single-ventricle survival
- Conditions
- Heart Defects, Congenital
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Queen Silvia Children's Hospital, Gothenburg, Sweden, Lund University Hospital
- Study start
- 1 Jan 1994 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.
Key inclusion criteria (1 listed)
- Operated with single-ventricle palliation between January 1994 and May 2017 in Sweden.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-ventricle palliation surgerySingle-ventricle palliation surgery | Procedure or surgery | – |
Primary outcome
Survival
Time frame: Until death or end of follow-up (December 31st 2017)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Derived from this study: PubMed 38497454Dalen 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.
- Individual participant dataSharing planned: No
Related trials for Heart Defects, Congenital
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital, run by Karolinska University Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: Until death or end of follow-up (December 31st 2017)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019; AzTrials last refreshed its copy on 1 Nov 2026.