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

This study has been completed.
Sponsor:
Collaborators:
Pediatric Heart Network
Information provided by:
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00115934
First received: June 26, 2005
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Heart Defects, Congenital
Procedure: Blalock-Taussig pulmonary artery shunt
Procedure: Right ventricular to pulmonary artery shunt
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Proportion of Patients Who Died or Received a Heart Transplant [ Time Frame: Measured at 12 months ] [ Designated as safety issue: Yes ]
    The primary outcome was the proportion of patients who died or had cardiac transplantation 12 months after randomization.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    This secondary outcome was the proportion of deaths or cardiac transplantation over time from randomization to the end of the trial.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Echocardiographic Measures of Heart Size and Function: RV End-diastolic Volume Indexed to BSA [ Time Frame: Measured at 14 months of age ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Echocardiographic Measures of Heart Size and Function: RV End-systolic Volume Indexed to BSA [ Time Frame: Measured at 14 months of age ] [ Designated as safety issue: Yes ]
    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.

  • Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction [ Time Frame: Measured post-Norwood, an average of 17 days post-Norwood ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • Echocardiographic Measures of Heart Size and Function: RV Ejection Fraction [ Time Frame: Measured at 14 months of age ] [ Designated as safety issue: Yes ]
    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.

  • Angiographic Findings: Left Pulmonary Artery Size [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ] [ Designated as safety issue: Yes ]
    Diameter of distal left pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

  • Angiographic Findings: Right Pulmonary Artery Size [ Time Frame: Measured pre-stage II surgery, on average 26 days prior to stage II palliation ] [ Designated as safety issue: Yes ]
    Diameter of distal right pulmonary artery. Angiograms were performed at the time points relative to the second palliative surgery (pre-Stage II).

  • Unintended Cardiovascular Interventional Procedures [ Time Frame: From Randomization to 12 months ] [ Designated as safety issue: Yes ]
    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.

  • Complications: Total Number Experienced During Norwood Hospitalization [ Time Frame: Norwood Hospitalization, an average of 36 days ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 555
Study Start Date: May 2005
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: RV to PA or Sano procedure

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115934

Locations
United States, California
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, Florida
Cardiac Surgical Associates
St. Petersburg, Florida, United States, 33709
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30033
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Health System/Mott Hospital
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
New England Research Institutes
Pediatric Heart Network
Investigators
Principal Investigator: Lynn Sleeper, ScD New England Research Institutes, Watertown, MA
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lynn Sleeper, ScD, PI, New England Research Institutes, Watertown, MA
ClinicalTrials.gov Identifier: NCT00115934     History of Changes
Other Study ID Numbers: 194, U01HL068270, U01HL068269, U01HL068279, U01HL068281, U01HL068285, U01HL068288, U01HL068290, U01HL068292
Study First Received: June 26, 2005
Results First Received: September 14, 2010
Last Updated: August 2, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 22, 2014