Heart DefectsSVRIINCT02110823
Single Ventricle Reconstruction Extension Study (SVR II) - Pediatric Heart Network
An observational study of Heart Defects, run by Carelon Research.
Trial summary
The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt (MBTS) or right ventricle to pulmonary… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Heart Defects
- How many people
- 325 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Jun 2025
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Follow up of subjects originally enrolled in the SVR trial
Who may be able to join
- Randomized subject in the Single Ventricle Reconstruction Trial
Who cannot join
- No subjects enrolled in the the original SVR Trial will be excluded from analysis of the primary endpoint
About this study
Official title: Single Ventricle Reconstruction Extension Study (A Study Conducted by the Pediatric Heart Network)
The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).
The purpose of this study is to learn if children (2-6 years of age) who were enrolled in the SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after surgery.
Read the detailed description
Among critical congenital heart lesions, hypoplastic left heart syndrome (HLHS) and related single right ventricle (RV) anomalies are associated with the highest morbidity and mortality. The first stage in palliation for patients with these defects is the Norwood procedure. The essential components of the Norwood procedure include (1) an atrial septectomy, (2) anastomosis of the proximal pulmonary artery to the aorta with homograft augmentation of the aortic arch, and (3) establishment of a source of pulmonary blood flow, with either a modified Blalock-Taussig shunt (MBTS) or the right ventricle to pulmonary artery (RV-to-PA) shunt. In May 2005, the Pediatric Heart Network began a multi-center, randomized trial, the Single Ventricle Reconstruction (SVR) Trial, comparing outcomes in subjects with HLHS or other single RV anomalies palliated using the Norwood procedure with either a MBTS or the RV-to-PA shunt. The primary outcome of this trial was freedom from death or cardiac transplantation by 12 months post-randomization.
The Single Ventricle Reconstruction Extension (SVR II) Study is an extension of the SVR Trial that compares clinical outcomes and RV performance following the RV-to-PA shunt versus MBTS modifications of the Norwood procedure in subjects at 6 years post-randomization. Data is collected annually between ages 2 and 6 years, as well as before and after the Fontan surgery. Vital status and medical history is ascertained annually until the last enrolled subject is 6 years old. Data is obtained through medical record review, phone interview with the parent or guardian, electrocardiography (ECG), core laboratory analysis of echocardiographic images and Holter monitors, and completion of questionnaires regarding neurodevelopmental outcomes, behavior, health-related quality of life, and family functioning. The primary outcome variable in SVR II will be freedom from death or cardiac transplantation at 6 years post-randomization. All subjects who were randomized in the SVR trial will be included in analysis of this endpoint.
- Conditions
- Heart Defects
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from death and cardiac transplantation at 6 years post-randomization.
Measured: Assessed annually until the last enrolled subject reaches 6 years of age.
Secondary outcomes (7)
Direct and indirect measures of right ventricle (RV) systolic and diastolic function.
- RV ejection fraction by echocardiogram pre-Fontan and at 6 years.
- RV fractional area change pre-Fontan and at 6 years post-randomization.
- Severity of tricuspid regurgitation by echocardiogram pre-Fontan and at 6 years.
- Heart Failure Class pre-Fontan and at 3, 4, 5, and 6 years.
- Somatic growth pre-Fontan and annually from ages 2-6 years.
Measured: Pre-Fontan, and 6 years of age
6 years post randomization
Measured: post procedure up to 6 years post randomization
Incidence of arrhythmias.
- Diagnosis of ventricular arrhythmias by 6 years.
- Diagnosis of atrial arrhythmias by 6 years.
Measured: Assessed once, at 6 years of age
Neurodevelopment.
Ages \& Stages Questionnaires (ASQ)
Measured: Questionnaires completed at ages 3, 4, 5, and 6 years
Behavior
- Behavior Assessment System for Children, Second Edition (BASC-2)
- Vineland Adaptive Behavior Scales
Measured: Questionnaires completed at ages 3, 4, 5, and 6 years
Health-related quality of life
- Pediatric Quality of Life Inventory (PedsQL)
- Children's Health Questionnaire Parent Form 50-Item (CHQ-PF50) Physical and Psychosocial Function Summary
Measured: Questionaires completed at ages 3, 4, 5 and 6 years
Family function
Impact on Family Scale Functional States II-R
Measured: Questionnaires completed at ages 3, 4, 5, and 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2008
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (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 DefectsStudies 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
- Prospective
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110823
- Sponsor's protocol ID
- U10HL068270-4a
- Other IDs
- U10HL068270
- Acronym
- SVRII
- Status last verified
- Feb 2024
- First submitted
- 7 Apr 2014
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dolgner SJ, Tjoeng YL, Chan T. Analysis of the Single Ventricle Reconstruction Trial Using Restricted Mean Survival Time and Shunt Type Received. J Am Heart Assoc. 2022 Sep 20;11(18):e025978. doi: 10.1161/JAHA.122.025978. Epub 2022 Sep 8. No abstract available.
PubMed 36073629
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ventricle Reconstruction Extension Study (A Study Conducted by the Pediatric Heart Network)
- ClinicalTrials.gov ID
- NCT02110823
- Acronym / sponsor ID
- SVRII / U10HL068270-4a
- Conditions
- Heart Defects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2008 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 10 Apr 2014 (estimated)
- 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.
The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation). Infants enrolled in the trial got one of two kinds of shunts during the Norwood; a modified Blalock-Taussig shunt (MBTS) or right ventricle to pulmonary artery shunt (RV-to-PA shunt).
The purpose of this study is to learn if children (2-6 years of age) who were enrolled in the SVR Trial do better with one of the two shunts (MBTS or RV-to-PA) in the years after surgery.
Detailed description
Among critical congenital heart lesions, hypoplastic left heart syndrome (HLHS) and related single right ventricle (RV) anomalies are associated with the highest morbidity and mortality. The first stage in palliation for patients with these defects is the Norwood procedure. The essential components of the Norwood procedure include (1) an atrial septectomy, (2) anastomosis of the proximal pulmonary artery to the aorta with homograft augmentation of the aortic arch, and (3) establishment of a source of pulmonary blood flow, with either a modified Blalock-Taussig shunt (MBTS) or the right ventricle to pulmonary artery (RV-to-PA) shunt. In May 2005, the Pediatric Heart Network began a multi-center, randomized trial, the Single Ventricle Reconstruction (SVR) Trial, comparing outcomes in subjects with HLHS or other single RV anomalies palliated using the Norwood procedure with either a MBTS or the RV-to-PA shunt. The primary outcome of this trial was freedom from death or cardiac transplantation by 12 months post-randomization.
The Single Ventricle Reconstruction Extension (SVR II) Study is an extension of the SVR Trial that compares clinical outcomes and RV performance following the RV-to-PA shunt versus MBTS modifications of the Norwood procedure in subjects at 6 years post-randomization. Data is collected annually between ages 2 and 6 years, as well as before and after the Fontan surgery. Vital status and medical history is ascertained annually until the last enrolled subject is 6 years old. Data is obtained through medical record review, phone interview with the parent or guardian, electrocardiography (ECG), core laboratory analysis of echocardiographic images and Holter monitors, and completion of questionnaires regarding neurodevelopmental outcomes, behavior, health-related quality of life, and family functioning. The primary outcome variable in SVR II will be freedom from death or cardiac transplantation at 6 years post-randomization. All subjects who were randomized in the SVR trial will be included in analysis of this endpoint.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Follow up of subjects originally enrolled in the SVR trial
Key inclusion criteria (1 listed)
- Randomized subject in the Single Ventricle Reconstruction Trial
Key exclusion criteria (1 listed)
- No subjects enrolled in the the original SVR Trial will be excluded from analysis of the primary endpoint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from death and cardiac transplantation at 6 years post-randomization.
Time frame: Assessed annually until the last enrolled subject reaches 6 years of age.
7 secondary outcomes
Direct and indirect measures of right ventricle (RV) systolic and diastolic function.
Time frame: Pre-Fontan, and 6 years of age
6 years post randomization
Time frame: post procedure up to 6 years post randomization
Incidence of arrhythmias.
Time frame: Assessed once, at 6 years of age
Neurodevelopment.
Time frame: Questionnaires completed at ages 3, 4, 5, and 6 years
Behavior
Time frame: Questionnaires completed at ages 3, 4, 5, and 6 years
Health-related quality of life
Time frame: Questionaires completed at ages 3, 4, 5 and 6 years
Family function
Time frame: Questionnaires completed at ages 3, 4, 5, and 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 36073629Dolgner SJ, Tjoeng YL, Chan T. Analysis of the Single Ventricle Reconstruction Trial Using Restricted Mean Survival Time and Shunt Type Received. J Am Heart Assoc. 2022 Sep 20;11(18):e025978. doi: 10.1161/JAHA.122.025978. Epub 2022 Sep 8. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, run by Carelon Research.
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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Freedom from death and cardiac transplantation at 6 years post-randomization. (time frame: Assessed annually until the last enrolled subject reaches 6 years of age.). 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 NCT02110823, 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 8 Feb 2024.