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

March 22, 2016 updated by: HealthCore-NERI

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital for Sick Children
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Alfred I. DuPont Hospital for Children
    • Florida
      • St. Petersburg, Florida, United States, 33709
        • Cardiac Surgical Associates
    • Georgia
      • Atlanta, Georgia, United States, 30033
        • Children's Healthcare of Atlanta at Egleston
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System/Mott Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia College of Physicians and Surgeons
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MBTS
Blalock-Taussig pulmonary artery shunt
Procedure: Blalock-Taussig pulmonary artery shunt
Performed at stage I palliative surgery for babies born with HLHS
Other Names:
  • MBTS procedure
ACTIVE_COMPARATOR: RVPAS
Right ventricular to pulmonary artery shunt
Procedure: Right ventricular to pulmonary artery shunt
Performed at stage I palliative surgery for babies born with HLHS
Other Names:
  • RV to PA or Sano procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Randomization to the End of the Trial, an average of 32 months
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.
Measured post-Norwood, an average of 17 days post-Norwood
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.
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
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.
Measured at 14 months of age
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.
Measured post-Norwood, an average of 17 days post-Norwood
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.
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
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.
Measured at 14 months of age
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.
Measured post-Norwood, an average of 17 days post-Norwood
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.
Measured pre-stage II surgery, an average of 15 days pre-stage II surgery
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.
Measured at 14 months of age
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).
Measured pre-stage II surgery, on average 26 days prior to stage II palliation
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).
Measured pre-stage II surgery, on average 26 days prior to stage II palliation
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.
From Randomization to 12 months
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.
Norwood Hospitalization, an average of 36 days
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.
From Norwood Discharge to Stage II discharge, an average of 4.2 months
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.
From Stage II Discharge to 14 Months of Age, an average of 8.9 months

Collaborators and Investigators

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

Sponsor

HealthCore-NERI

Collaborators

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

Investigators

  • Principal Investigator: Julie E Miller, MPH, New England Research Institutes, Watertown, MA

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

May 1, 2005

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

June 26, 2005

First Submitted That Met QC Criteria

June 26, 2005

First Posted (ESTIMATE)

June 27, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 194
  • U01HL068292 (U.S. NIH Grant/Contract)
  • U01HL068290 (U.S. NIH Grant/Contract)
  • U01HL068288 (U.S. NIH Grant/Contract)
  • U01HL068285 (U.S. NIH Grant/Contract)
  • U01HL068281 (U.S. NIH Grant/Contract)
  • U01HL068279 (U.S. NIH Grant/Contract)
  • U01HL068270 (U.S. NIH Grant/Contract)
  • U01HL068269 (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.

Clinical Trials on Heart Defects, Congenital

Clinical Trials on Blalock-Taussig pulmonary artery shunt

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe