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Completed

NCT Number: NCT00115934

Comparison of Two Types of Shunts in Infants With Single Ventricle Defect Undergoing Staged Reconstruction--Pediatric Heart Network

This trial will evaluate the efficacy and safety of the modified Blalock-Taussig shunt (MBTS) compared to the right ventricle to pulmonary artery (RV-to-PA) shunt; compare the effect of the MBTS to that of the RV-to-PA shunt on the incidence of death or cardiac transplantation at 12 months post randomization; and compare the effect of the two shunts on intensive care unit (ICU) morbidity, unintended cardiovascular interventional procedures, right ventricular function, tricuspid valve regurgitation, pulmonary artery growth, and neurodevelopmental outcome.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Sick Children, Toronto, Ontario, Canada

Loading trial locations.

About this study

BACKGROUND:

Hypoplastic left heart syndrome (HLHS) and related single right ventricle anomalies are the highest risk congenital cardiovascular malformations. Surgical repair begins with the Norwood procedure during the newborn period, a stage II procedure at 4 to 6 months of age, and Fontan procedure at 18 to 36 months. The Norwood procedure remains one of the highest risk procedures in congenital heart surgery. A few small nonrandomized studies of a novel approach to the Norwood procedure have reported improved outcomes. This new approach uses a RV-to-PA shunt to provide pulmonary blood flow rather than the standard MBTS. This multi-center, randomized clinical trial will evaluate early and intermediate-term outcomes for patients undergoing a Norwood procedure with either the RV-to-PA shunt or the MBTS.

This study has been approved by the Institutional Review/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Children's Hospital of Wisconsin, Milwaukee, WI

University of Michigan, Ann Arbor, MI

Cincinnati Children's Hospital Medical Center, Cincinnati, OH

Children's Hospital of Los Angeles, Los Angeles, CA

Egleston Children's Hospital, Emory University, Atlanta, GA

Congenital Heart Institute of Florida, University of South Florida, St. Petersburg, FL

Alfred I. duPont Hospital for Children, Wilmington, DE

DESIGN NARRATIVE:

This is a prospective, randomized clinical trial of the RV-to-PA shunt versus MBTS in patients undergoing a Norwood procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of hypoplastic left heart syndrome or related single, morphologic right ventricle anomaly
  • Planned Norwood procedure
  • Informed consent of parent(s) or legal guardian

Exclusion criteria

  • Single, morphologic left ventricle anomaly
  • Preoperative identification of anatomy rendering either an MBTS or an RV-to-PA shunt technically impossible
  • Any major congenital abnormality (i.e., congenital diaphragmatic hernia, tracheoesophageal fistula) or acquired extra-cardiac disorder (e.g., meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis) that, in the opinion of the investigator, could independently affect the likelihood of the subject meeting the primary endpoint

Treatment and study plan

Blalock-Taussig pulmonary artery shunt

Procedure

Performed at stage I palliative surgery for babies born with HLHS

Other names: MBTS procedure

Right ventricular to pulmonary artery shunt

Procedure

Performed at stage I palliative surgery for babies born with HLHS

Other names: RV to PA or Sano procedure

Primary outcomes

  1. Proportion of Patients Who Died or Received a Heart Transplant

    Time frame: Measured at 12 months

    The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.

Secondary outcomes

  1. Proportion of Deaths or Heart Transplants Over Time From Randomization to the End of the Trial

    Time frame: From Randomization to the End of the Trial, an average of 32 months

    This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.

  2. Echocardiographic Measures of Heart Size and Function: Right Ventricle (RV) End-diastolic Volume Indexed to Body Surface Area (BSA)

    Time frame: Measured post-Norwood, an average of 17 days post-Norwood

    Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  3. Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA

    Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

    Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  4. Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA

    Time frame: Measured at 14 months of age

    Right ventricular end-diastolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  5. Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA

    Time frame: Measured post-Norwood, an average of 17 days post-Norwood

    Right ventricular end-systolic volume indexed to BSA. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  6. Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA

    Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

    Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  7. Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA

    Time frame: Measured at 14 months of age

    Right ventricular end-systolic volume indexed to BSA^1.3. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  8. Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction

    Time frame: Measured post-Norwood, an average of 17 days post-Norwood

    Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  9. Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction

    Time frame: Measured pre-stage II surgery, an average of 15 days pre-stage II surgery

    Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  10. Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction

    Time frame: Measured at 14 months of age

    Right ventricular ejection fraction: 100 x (RV end-diastolic volume - RV end-systolic volume)/RV end-diastolic volume. Echocardiograms were performed at time points relative to the two palliative surgeries (post-Norwood and pre-Stage II) as well as at the specific time point of 14 months of age.

  11. Angiographic Findings: Left Pulmonary Artery Size

    Time frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation

    Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

  12. Angiographic Findings: Right Pulmonary Artery Size

    Time frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation

    Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

  13. Unintended Cardiovascular Interventional Procedures

    Time frame: From Randomization to 12 months

    Unintended cardiovascular procedures included balloon dilation of the shunt or branch pulmonary arteries, stent placement in the shunt or branch pulmonary arteries, shunt revision, crossover between MBTS and RVPAS shunt, balloon dilation, stent placement or surgical revisions of the neo-aorta, and pulmonary artery reconstructions, other than those undertaken as a standard component of the stage II procedure. The number of cardiovascular procedures was analyzed; trial participants may have had more than one unintended cardiovascular. procedure.

  14. Complications: Total Number Experienced During Norwood Hospitalization

    Time frame: Norwood Hospitalization, an average of 36 days

    Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

  15. Complications: Total Number Experienced From Norwood Discharge to Stage II Discharge

    Time frame: From Norwood Discharge to Stage II discharge, an average of 4.2 months

    Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

  16. Complications: Total Number Experienced From Stage II Discharge to 14 Months of Age

    Time frame: From Stage II Discharge to 14 Months of Age, an average of 8.9 months

    Complications, reported as 'Other Adverse Events' in the safety section, are those adverse events that were not considered serious. Many normal peri-operative occurrences meet the standard criteria of an adverse event; therefore, for this trial a serious adverse event was (a) death, (b) acute shunt failure requiring intervention, (c) cardiac arrest requiring CPR and medications, (d) cardiopulmonary insufficiency requiring ECMO, (e) cardiovascular re-operation (unplanned), (f) necrotizing enterocolitis requiring laparotomy, and (g) any event considered by the study investigator as serious.

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pediatric Heart Network

Registry information

Official study title

Trial of Right Ventricular Versus Modified Blalock-Taussig Shunt in Infants With Single Ventricle Defect Undergoing Staged Reconstruction (A Trial Conducted by the Pediatric Heart Network)

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 27, 2005
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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