Single Ventricle Reconstruction Extension Study (SVR II) - Pediatric Heart Network

NCT02110823 | Active Not Recruiting DMC

• 2 other identifiers: U10HL068270-4aU10HL068270
• Study Type: observational
• Target: 325
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Heart Defects

Outcome Measures

Primary Outcomes (1)

• Freedom from death and cardiac transplantation at 6 years post-randomization.

  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.

  Pre-Fontan, and 6 years of age

• 6 years post randomization

  post procedure up to 6 years post randomization

• Incidence of arrhythmias.

  Assessed once, at 6 years of age

• Neurodevelopment.

  Questionnaires completed at ages 3, 4, 5, and 6 years

• Behavior

  Questionnaires completed at ages 3, 4, 5, and 6 years

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Follow up of subjects originally enrolled in the SVR trial

You may qualify if:

• Randomized subject in the Single Ventricle Reconstruction Trial

You may not qualify if:

• No subjects enrolled in the the original SVR Trial will be excluded from analysis of the primary endpoint

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (1)

• 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.

  PMID: 36073629 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The SVR II study will collect biological specimens to bank in an established biorepository as a resource for future, hypothesis-driven studies from families who provide separate informed consent. When possible, blood will be drawn, processed, and stored in such a way as to permit both genetic studies and studies of serum biomarkers. The intent is to obtain blood from study subjects and parents (i.e., "trios"). When obtaining blood is not possible, however, saliva will be obtained so that at least genetic information can be stored for future studies.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2008
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02