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

February 7, 2024 updated by: Carelon Research

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Follow up of subjects originally enrolled in the SVR trial

Description

Inclusion Criteria:

  • Randomized subject in the Single Ventricle Reconstruction Trial

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Assessed annually until the last enrolled subject reaches 6 years of age.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct and indirect measures of right ventricle (RV) systolic and diastolic function.
Time Frame: Pre-Fontan, and 6 years of age
  • 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.
Pre-Fontan, and 6 years of age
6 years post randomization
Time Frame: post procedure up to 6 years post randomization
post procedure up to 6 years post randomization
Incidence of arrhythmias.
Time Frame: Assessed once, at 6 years of age
  • Diagnosis of ventricular arrhythmias by 6 years.
  • Diagnosis of atrial arrhythmias by 6 years.
Assessed once, at 6 years of age
Neurodevelopment.
Time Frame: Questionnaires completed at ages 3, 4, 5, and 6 years
Ages & Stages Questionnaires (ASQ)
Questionnaires completed at ages 3, 4, 5, and 6 years
Behavior
Time Frame: Questionnaires completed at ages 3, 4, 5, and 6 years
  • Behavior Assessment System for Children, Second Edition (BASC-2)
  • Vineland Adaptive Behavior Scales
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
  • Pediatric Quality of Life Inventory (PedsQL)
  • Children's Health Questionnaire Parent Form 50-Item (CHQ-PF50) Physical and Psychosocial Function Summary
Questionaires completed at ages 3, 4, 5 and 6 years
Family function
Time Frame: Questionnaires completed at ages 3, 4, 5, and 6 years
Impact on Family Scale Functional States II-R
Questionnaires completed at ages 3, 4, 5, and 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carelon Research

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2008

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimated)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U10HL068270-4a
  • U10HL068270 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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